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Trial record 1 of 1 for:    NCT03387813
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Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03387813
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure, Systolic Heart Failure, Diastolic Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class IV Heart Failure,Congestive Heart Failure With Reduced Ejection Fraction Heart Failure With Normal Ejection Fraction Heart Failure; With Decompensation Device: CardioMEMS™ HF System Not Applicable

Detailed Description:

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.

The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).

The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemodynamic-GUIDEd Management of Heart Failure
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Randomized Arm - Treatment Group

Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System.

All subjects will receive a CardioMEMS™ HF System.

Device: CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System

Experimental: Randomized Arm - Control Group

Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System.

All subjects will receive a CardioMEMS™ HF System.

Device: CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System

Experimental: Single Arm

Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System.

All subjects will receive a CardioMEMS™ HF System.

Device: CardioMEMS™ HF System
The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
  • CardioMEMS HF System




Primary Outcome Measures :
  1. (Randomized Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality [ Time Frame: 12 months post-implantation ]

    The composite of:

    1. The number of recurrent HFHs
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    3. The number of deaths of any cause

    added together with equal weighting into a total number of events


  2. (Single Arm) Composite outcome of (1) HFHs, (2) intravenous diuretic visits, and (3) all-cause mortality [ Time Frame: 12 months post-implantation ]

    The composite outcome of:

    1. The number of recurrent HFHs
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    3. The number of deaths of any cause

    added together with equal weighting into a total number of events



Secondary Outcome Measures :
  1. (Randomized Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits [ Time Frame: 12 months post-implantation ]

    The composite outcome of:

    1. The number of recurrent HFHs
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    added together with equal weighting into a total number of events


  2. (Randomized Arm) EQ-5D-5L [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire

  3. (Randomized Arm) KCCQ-12 [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  4. (Randomized Arm) 6MHW Test [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Six Minute Hall Walk (6MHW) Test Distance

  5. (Randomized Arm) HFHs [ Time Frame: 12 months post-implantation ]
    The number of recurrent HFHs

  6. (Randomized Arm) Intravenous diuretic visits [ Time Frame: 12 months post-implantation ]
    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

  7. (Randomized Arm) All-cause mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths of any cause

  8. (Randomized Arm) Safety: Freedom from DSRCs [ Time Frame: 12 months post-implantation ]
    Freedom from device/system related complications (DSRCs)

  9. (Single Arm) Composite outcome of (1) HFHs and (2) intravenous diuretic visits [ Time Frame: 12 months post-implantation ]

    The composite outcome of:

    1. The number of recurrent HFHs
    2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    added together with equal weighting into a total number of events


  10. (Single Arm) HFHs post- vs. pre-implantation [ Time Frame: 12 months post-implantation ]
    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

  11. (Single Arm) HFHs [ Time Frame: 12 months post-implantation ]
    The number of HFHs

  12. (Single Arm) Intravenous diuretic visits [ Time Frame: 12 months post-implantation ]
    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

  13. (Single Arm) All-cause mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths of any cause

  14. (Single Arm) Safety: Freedom from DSRCs [ Time Frame: 12 months post-implantation ]
    Freedom from DSRCs


Other Outcome Measures:
  1. (Randomized Arm) Cardiovascular mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths with cardiovascular cause

  2. (Randomized Arm) All-cause hospitalizations [ Time Frame: 12 months post-implantation ]
    The number of hospitalizations of any cause

  3. (Randomized Arm) Frequency of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of subject uploads of PA pressure

  4. (Randomized Arm) Frequency of clinician review of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of clinician review of subject uploads of PA pressure

  5. (Randomized Arm) HF medication changes [ Time Frame: 12 months post-implantation ]
    The number of changes in HF medications

  6. (Randomized Arm) PA pressure measurements [ Time Frame: Baseline through 12 months post-implantation ]
    PA pressure measurements

  7. (Randomized Arm) NT-proBNP (or BNP) [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    NT-proBNP (or BNP) measurements

  8. (Randomized Arm) HFHs post- vs. pre-implantation [ Time Frame: 12 months post-implantation ]
    The number of HFHs at 12 months post-implantation compared to the num ber of HFHs in the 12 months prior to implantation

  9. (Single Arm) EQ-5D-5L [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the EQ-5D-5L Questionnaire

  10. (Single Arm) KCCQ-12 [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    Health status as assessed by the KCCQ-12

  11. (Single Arm) 6MHW Test [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    6MHW Test Distance

  12. (Single Arm) Cardiovascular mortality [ Time Frame: 12 months post-implantation ]
    The number of deaths of cardiovascular cause

  13. (Single Arm) All-cause hospitalizations [ Time Frame: 12 months post-implantation ]
    The number of hospitalizations of any cause

  14. (Single Arm) Frequency of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of subject uploads of PA pressure

  15. (Single Arm) Frequency of clinician review of subject PA pressure uploads [ Time Frame: 12 months post-implantation ]
    The frequency of clinician review of subject uploads of PA pressure

  16. (Single Arm) HF medication changes [ Time Frame: 12 months post-implantation ]
    The number of changes in HF medications

  17. (Single Arm) PA pressure measurements [ Time Frame: Baseline through 12 months post-implantation ]
    PA pressure measurements

  18. (Single Arm) NT-proBNP (or BNP) [ Time Frame: Baseline, 6, and 12 months post-implantation ]
    NT-proBNP (or BNP) measurements



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:

    a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.

  2. GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
  3. GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
  4. HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:

    1. Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
    2. Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
    3. Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
  5. ≥ 18 years of age
  6. Chest circumference of < 65 inches, if BMI is > 35 kg/m2
  7. Written informed consent obtained from subject
  8. Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements

Exclusion Criteria:

  1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)
  2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  3. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
  4. NYHA Class IV HF patients with:

    1. Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR
    2. Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
  5. Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
  6. Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
  7. Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
  8. Implanted with mechanical right heart valve(s)
  9. Unrepaired severe valvular disease
  10. Pregnant or planning to become pregnant in the next 12 months
  11. An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).
  12. History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
  13. Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
  14. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent
  15. Enrollment into another trial with an active treatment arm
  16. Anticipated life expectancy of < 12 months
  17. Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387813


Contacts
Layout table for location contacts
Contact: Rebecca Apruzzese 818-493-4210 rebecca.apruzzese@abbott.com
Contact: Nessa Johnson, PhD 651-756-3738 nessa.johnson@abbott.com

Locations
Hide Hide 139 study locations
Layout table for location information
United States, Arizona
Banner-University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Contact: Monya Pierce       monyap@email.arizona.edu   
Principal Investigator: Radha Gopalan, MD         
Arizona Cardiovascular Research Center Recruiting
Phoenix, Arizona, United States, 85016
Contact: Sophie Raymond       sraymond@azheartrhythm.com   
Principal Investigator: Vijendra Swarup, MD         
Phoenix Cardiovascular Research Group Recruiting
Phoenix, Arizona, United States, 85018
Contact: Helen Foughi       hfoughi@insightmedr.com   
Principal Investigator: Madhavagopal Cherukuri, MD         
University of Arizona Recruiting
Tucson, Arizona, United States, 85719
Contact: Catherine MacDonald    520-626-4899    cmacdonald@shc.arizona.edu   
Principal Investigator: Jennifer Cook, MD, FAHA         
United States, Arkansas
Washington Regional Medical Center Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Mary Craff, RN    479-463-7856    mcraff@wregional.com   
Principal Investigator: Joel Carver, MD         
Baptist Health Medical Center Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Amy Ford       amy.ford@baptist-health.org   
Principal Investigator: Patrick Campbell, MD         
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Victoria Mcintosh    501-748-8425    victoria.mcintosh@arheart.com   
Principal Investigator: Scott Beau, MD         
United States, California
John Muir Medical Center Recruiting
Concord, California, United States, 94520
Contact: Craig Griffiths    925-674-2287    craig.griffiths@johnmuirhealth.com   
Principal Investigator: Neal White, MD         
St. Helena Hospital Recruiting
Deer Park, California, United States, 94574
Contact: Susan Sherman       Shermasr@ah.org   
Principal Investigator: Kathleen Tong, MD         
Scripps Health Recruiting
La Jolla, California, United States, 92037
Contact: Matthew Hollen    858-824-5247    Hollen.Matthew@scrippshealth.org   
Principal Investigator: James Heywood, MD         
University of California at San Diego (UCSD) Medical Center Recruiting
La Jolla, California, United States, 92037
Contact: Bettina Collins       brcollins@ucsd.edu   
Principal Investigator: Howie Tran, MD         
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Ramos    323-442-7983    melissa.ramos@med.usc.edu   
Principal Investigator: Luanda Grazette, MD         
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Sandra Rodriguez       SARODRIGUEZ@MEDNET.UCLA.EDU   
Principal Investigator: Ali Nsair, MD         
Eisenhower Medical Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Sharon Kunic    760-346-0642    skunic@emc.org   
Principal Investigator: Leon Feldman, MD         
Sutter Medical Center, Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Beverly Seiler       seilerb@sutterhealth.org   
Principal Investigator: Zi-Jian Xu, MD         
Mercy Medical Group - Cardiology Recruiting
Sacramento, California, United States, 95819
Contact: Dawn Warner    916-453-4947    dawn.warner@dignityhealth.org   
Principal Investigator: Munir Janmohamed, MD         
San Diego Cardiac Center Recruiting
San Diego, California, United States, 92123
Contact: Chris Kohlmyer    858-244-6886    ckohlmyer@sdcardiac.com   
Principal Investigator: Brian Jaski, MD         
California Pacific Medical Center - Van Ness Campus Recruiting
San Francisco, California, United States, 94109
Contact: Milena Ferreira       ferreiml@sutterhealth.org   
Principal Investigator: Jared Herr, MD         
Ventura Cardiology Consultants Recruiting
Ventura, California, United States, 93003
Contact: Erin Ross    805-648-2763    erinross.vcc@gmail.com   
Principal Investigator: Thomas Kong, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Mercedes Zirbes         
Principal Investigator: Natasha Altman, MD         
North Colorado Medical Center Recruiting
Greeley, Colorado, United States, 80631
Contact: Amber Tschillard       Amber.Tschillard@bannerhealth.com   
Principal Investigator: Sasikanth Adigopula, MD         
South Denver Cardiology Associates PC Recruiting
Littleton, Colorado, United States, 80120
Contact: Mary Soltau    303-703-2191    msoltau@southdenver.com   
Principal Investigator: Ira Dauber, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Arben Ademi       Arben.Ademi@hhchealth.org   
Principal Investigator: Howard Haronian, MD         
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Romy Chamoun       romy.chamoun@yale.edu   
Principal Investigator: Richard Soucier, MD         
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Deborah Moore       dmoore@Christianacare.org   
Principal Investigator: Sourin Banerji, MD         
United States, District of Columbia
George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Lorraine Marshall       lmarshall@mfa.gwu.edu   
Principal Investigator: Gurusher Panjrath, MD         
United States, Florida
Bethesda Memorial Hospital Recruiting
Boynton Beach, Florida, United States, 33466
Contact: Gabriela Reyes       greyes@rpna.net   
Principal Investigator: Andres Ruiz, MD         
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Allison Timmons       Allison.Timmons@baycare.org   
Principal Investigator: Parag Patel, MD         
Florida Heart Center Withdrawn
Fort Pierce, Florida, United States, 34950
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33020
Contact: Ricardo Guedes       rguedes@mhs.net   
Principal Investigator: Maria Del Rosario Avila, MD         
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32216
Contact: Mary Hudson    904-493-3333    mhudson@firstcoastcardio.com   
Principal Investigator: Omer Zuberi, MD         
Memorial Hospital Jacksonville Recruiting
Jacksonville, Florida, United States, 32216
Contact: Elizabeth Breting    612-329-7274    elizabeth.breting@scresearch.net   
Principal Investigator: Sumant Lamba, MD         
Mercy Hospital Recruiting
Miami, Florida, United States, 33133
Contact: Reuben Camp       Reuben.Camp@hcahealthcare.com   
Principal Investigator: Alberto Interian, MD         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Deanna Allen    407-303-7556    deanna.allen2@flhosp.org   
Principal Investigator: Nirav Raval, MD         
Orlando Regional Medical Center Recruiting
Orlando, Florida, United States, 32806
Contact: Meghan Tinetti       meghan.tinetti@orlandohealth.com   
Principal Investigator: Peter Taylor, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Laurie Joughin       ljoughin@tgh.org   
Principal Investigator: Debbie Rinde-Hoffman, MD         
United States, Georgia
Piedmont Athens Regional Medical Center Recruiting
Athens, Georgia, United States, 30606
Contact: Gigi Davis    706-475-1828    gigi.davis@piedmont.org   
Principal Investigator: Catherine Marti, MD         
Emory University Hospital Withdrawn
Atlanta, Georgia, United States, 30322
University Hospital Recruiting
Augusta, Georgia, United States, 30901
Contact: Jennifer Hansen       jbhansen46@gmail.com   
Principal Investigator: Darshak Karia, MD         
WellStar Kennestone Hospital Recruiting
Marietta, Georgia, United States, 30060
Contact: Holly Holtxclaw         
Contact       krystal.holtzclaw@wellstar.org   
Principal Investigator: Hans Lee         
United States, Illinois
Northshore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Laurene Sherman       lsherman2@northshore.org   
Principal Investigator: Robert Gordon, MD         
Advocate Health and Hospitals Corporation Recruiting
Oakbrook Terrace, Illinois, United States, 60181
Contact: Josilyn Klimek    630-785-2671    josilyn.klimek@advocatehealth.com   
Principal Investigator: Maria Rosa Costanzo, MD         
United States, Indiana
St. Vincent Hospital Recruiting
Indianapolis, Indiana, United States, 46240
Contact: Bonnie Reilly    317-338-6161    Bonnita.reilly@ascension.org   
Principal Investigator: Ashwin Ravichandran, MD         
Heart Center of Lake County Recruiting
Merrillville, Indiana, United States, 46410
Contact: Kimberly Armstrong    219-884-9180    theheartcenterLCKA@yahoo.com   
Principal Investigator: Andre Artis, MD         
United States, Iowa
Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Megan Murphy, RN, BSN       mmurphy@iowaheart.com   
Principal Investigator: Jennifer Goerbig-Campbell, MD         
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Alyssa Boyce    913-588-9722    aboyce2@kumc.edu   
Principal Investigator: Andrew Sauer, MD         
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67226
Contact: Lindsey Steele       lindsey.steele@cckheart.com   
Principal Investigator: Aziz Maksoud, MD         
United States, Kentucky
University of Kentucky Withdrawn
Lexington, Kentucky, United States, 40536
United States, Louisiana
Our Lady of the Lake Hospital Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Anne Erwin    225-765-7659      
Principal Investigator: David Moll, MD         
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70361
Contact: Vicky Parfait       vicky.parfait@cardio.com   
Principal Investigator: Peter Fail, MD         
Louisiana State University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Stacey Ducombs-Isa    504-568-2349    sduco3@lsuhsc.edu   
Principal Investigator: Murtuza Ali, MD         
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Kelly Boudet, RN    504-842-5257    kboudet@ochsner.org   
Principal Investigator: Selim Krim, MD         
Advanced Cardiovascular Specialists Recruiting
Shreveport, Louisiana, United States, 71105
Contact: Katherine Chalamidas         
Contact       kchalamidas@acsdoctors.com   
Principal Investigator: Scott Wiggins, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Deborah Manuelian       dmanuelian@bwh.harvard.edu   
Principal Investigator: Sunil Kapur, MD         
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Noelle Bodkin       Noelle.Bodkin@umassmed.edu   
Principal Investigator: Jeffrey Shih, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Judit Grossi       jgrossi@med.umich.edu   
Principal Investigator: Todd Koelling         
McLaren Health Care Corporation Recruiting
Auburn Hills, Michigan, United States, 48326
Contact: Linda Jaskiewicz    989-894-3290    linda.jaskiewicz@mclaren.org   
Principal Investigator: Kalil Masri, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Kelsey Neaton       Kneaton1@hfhs.org   
Principal Investigator: Gillian Grafton         
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48912
Contact: Jessica Nixon       jessica.nixon@sparrow.org   
Principal Investigator: Gaurav Dhar, MD         
MidMichigan Medical Center-Midland Recruiting
Midland, Michigan, United States, 48640
Contact: Katie Kamyszek       katie.kamyszek@midmichigan.org   
Principal Investigator: Jeffrey Martindale, MD         
Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact: Angela Spencer    248-465-4828    angela.spencer@stjohn.org   
Principal Investigator: Marcel Zughaib, MD         
United States, Minnesota
Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Kari Thomas    612-863-7493    kari.m.thomas@allina.com   
Principal Investigator: Mosi Bennett, MD, PhD         
University of Minnesota Medical Center Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Coley Landvik       clandvik@umn.edu   
Principal Investigator: Tamas Alexy, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Janet Gatzke       gatzke.janet@mayo.edu   
Principal Investigator: Margaret rEDFIELD, MD         
St. Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Pam Clemens    320-251-2700    clemensp@centracare.com   
Principal Investigator: Jamie Pelzel, MD         
United States, Missouri
St. Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jackie Smith       Jnsmith@saint-lukes.org   
Principal Investigator: Taiyeb Khumri         
North Kansas City Hospital Recruiting
North Kansas City, Missouri, United States, 64116
Contact: Julie Dehner       julie.dehner@nkch.org   
Principal Investigator: David Hahn, MD         
Mercy Hospital St. Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Analyn Howells       analyn.howells@mercy.net   
Principal Investigator: Bruce Czarnik, MD         
United States, Nebraska
BryanLGH Heart Institute Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Nicci Thompson, RN    402-483-3290    nicci.thompson@bryanheart.com   
Principal Investigator: John Steuter, MD         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Kevin Liewer       kevin.liewer@unmc.edu   
Principal Investigator: Adam Burdorf, DO, MS         
United States, Nevada
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Lisa English       LEnglish@renown.org   
Principal Investigator: Thomas To, MD         
United States, New Hampshire
Catholic Medical Center Recruiting
Manchester, New Hampshire, United States, 03102
Contact: Alyssa Mancini    603-665-2443    alyssa.mancini@cmc-nh.org   
Principal Investigator: Robert Capodilupo, MD         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Lisa Romano       RomanoL@Deborah.org   
Principal Investigator: Kulpreet Barn, MD         
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Patricia Arakelian       patricia.arakelian@hackensackmeridian.org   
Principal Investigator: Kumar Satya, MD         
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Charese Koski    973-429-8333    ckoski@njcaheart.com   
Principal Investigator: Mark Zucker, MD         
Lourdes Cardiology Services Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Marisa Brown       MARISA.BROWN@lmanet.com   
Principal Investigator: Robert Mohapatra         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Deanna Garcia       deannag@nmhi.com   
Principal Investigator: Faisal Zaeem         
United States, New York
New York University Hospital Recruiting
New York, New York, United States, 10016
Contact: Stanley Cobos       Stanley.Cobos@nyulangone.org   
Principal Investigator: Tajinderpal Saraon, MD         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10019
Contact: Pilar Tlachi       pilar.tlachi@mountsinai.org   
Principal Investigator: Noah Moss, MD         
New York-Presbyterian/Columbia University Recruiting
New York, New York, United States, 10032
Contact: Yonandy Barrientos       yb2443@cumc.columbia.edu   
Principal Investigator: Kelly Axsom, MD         
Hudson Valley Cardiovascular Practice, P.C. Recruiting
Poughkeepsie, New York, United States, 12601
Contact: Jessica Darius    845-473-1188    jdarius@health-quest.org   
Principal Investigator: James Lyons, MD         
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Contact: Patricia Noll       Patricia.Noll@rochesterregional.org   
Principal Investigator: Scott Feitell, MD         
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Tanya Buchrieser    516-622-4528    tanya.buchrieser@chsli.org   
Principal Investigator: Rita Jermyn, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Krystal Winkler       Krystal.Winkler@carolinashealthcare.org   
Principal Investigator: Sanjeev Gulati, MD         
Vidant Medical Center Recruiting
Greenville, North Carolina, United States, 27835
Contact: Betsy Joll    252-847-0162    elizabeth.joll@vidanthealth.com   
Principal Investigator: Hassan Alhosaini, MD         
NC Heart and Vascular Research Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Tiffany Johnson    919-784-4031    tiffany.johnson@unchealth.unc.edu   
Principal Investigator: Christopher Chien, MD, FACC         
WakeMed Hospital Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Shamarra Gilbert       shgilbert@wakemed.org   
Principal Investigator: Frances Wood, MD         
United States, North Dakota
Sanford Research Recruiting
Fargo, North Dakota, United States, 58102
Contact: Her Yang       Her.Yang@SanfordHealth.org   
Principal Investigator: Hayan Al Maluli, MD         
United States, Ohio
Akron City Hospital Recruiting
Akron, Ohio, United States, 44309
Contact: Patty Kochanski, RN       pkochanski@summahealth.org   
Principal Investigator: Joseph Redle, MD         
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Terence Semenec, RN    216-983-4724    Terence.Semenec@UHhospitals.org   
Principal Investigator: Monique Robinson, MD         
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Barbara Gus       gusb@ccf.org   
Principal Investigator: Miriam Jacob, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Sarah Stockdale    614-292-4084    Sarah.Stockdale@osumc.edu   
Principal Investigator: Brent Lampert, MD         
Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Kitra Hunter    614-566-1262    Kitra.Hunter@ohiohealth.com   
Principal Investigator: Anupam Basuray, MD         
St. Elizabeth Health Center Recruiting
Youngstown, Ohio, United States, 44501
Contact: Patty Schuler       Patty_Schuler@mercy.com   
Principal Investigator: Hayah Kassis-George, MD         
United States, Oklahoma
Integris Baptist Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Adrienne Maximin    405-951-8213    adrienne.maximin@integrisok.com   
Principal Investigator: Douglas Horstmanshof, MD         
Oklahoma Heart Hospital South Recruiting
Oklahoma City, Oklahoma, United States, 73135
Contact: Mackenzie Taylor       mrtaylor@okheart.com   
Principal Investigator: Naeem Tahirkheli, MD         
Oklahoma Heart Institute at Utica Recruiting
Tulsa, Oklahoma, United States, 74133
Contact: Colene Holland Son       colene.hollandson@hillcrest.com   
Principal Investigator: Hoda Butrous, MD         
United States, Oregon
Providence Heart and Vascular Recruiting
Portland, Oregon, United States, 97225
Contact: Ellen Muir    503-216-2110    ellen.muir@providence.org   
Principal Investigator: Jacob Abraham, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Colleen Marchand    215-481-4661    colleen.marchand@jefferson.edu   
Principal Investigator: Donald Haas, MD         
Pinnacle Health System Recruiting
Harrisburg, Pennsylvania, United States, 17105
Contact: Gretchen Meise, RN    717-920-4400    gmeise@pinnaclehealth.org   
Principal Investigator: Roberto Hodara, MD         
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Katherine Loffredo    717-531-6855    kloffredo@pennstatehealth.psu.edu   
Principal Investigator: John Boehmer, MD         
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17603
Contact: Susan Pointer    717-544-1777    spointer2@lghealth.org   
Principal Investigator: Tareck Nossuli, MD, PhD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Caitlin Strachan       Caitlin.Strachan@Pennmedicine.upenn.edu   
Principal Investigator: Monique Tanna, MD         
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Carrie Malaczewski       MalaczeC@einstein.edu   
Principal Investigator: Sumeet Mainigi, MD         
Allegheny General Hospital - ASRI Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Joan Rossi    412-359-3293    joan.rossi@ahn.org   
Principal Investigator: Raymond Benza, MD         
The Reading Hospital and Medical Center Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Julie Sheidy    484-628-4317    julie.sheidy@towerhealth.org   
Principal Investigator: Jared Green, DO         
Main Line Health Center/Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Lisa Thome    484-476-2021    thomel@mlhs.org   
Principal Investigator: Christopher Droogan, DO         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kelly Franchetti       kfranchetti@lifespan.org   
Principal Investigator: Daniel Levine, MD         
United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Lauren Nixon       Lauren.Nixon@palmettohealth.org   
Principal Investigator: Rebecca Napier, MD         
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Grace Jones       grace.jones@prismahealth.org   
Principal Investigator: Jason Guichard         
United States, South Dakota
Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117
Contact: Shanon McElhany    605-312-2271    shanon.mcelhany@sanfordhealth.org   
Principal Investigator: Orvar Jonsson, MD         
United States, Tennessee
East Tennessee Heart Consultants Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Nancy Polakiewicz       nancy.polakiewicz@tennova.com   
Principal Investigator: Malcolm Foster, MD         
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
Contact: Kelly Bien       kbien@uthsc.edu   
Principal Investigator: John Jeffries, MD         
St Thomas Hospital Recruiting
Nashville, Tennessee, United States, 37205
Contact: Cassandra Wheeler       cassandra.wheeler@ascension.org   
Principal Investigator: Mark Aaron, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sherry Bowman, RN    615-343-4841    sherry.bowman@vanderbilt.edu   
Principal Investigator: Sandip Zalawadiya, MD         
United States, Texas
Seton Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Virginia Remeny    512-324-3434    vdremeny@ascension.org   
Principal Investigator: Ernest Haeusslein, MD         
Austin Heart Recruiting
Austin, Texas, United States, 78756
Contact: Alicia Bauman    512-206-3603    alicia.bauman@hcahealthcare.com   
Principal Investigator: Kunjan Bhatt, MD         
Baylor University Hospital Recruiting
Dallas, Texas, United States, 75246
Contact: Wanda Fikes    254-724-5373    wanda.fikes@BSWHealth.org   
Principal Investigator: Shelley Hall, MD         
John Peter Smith Hospital Recruiting
Fort Worth, Texas, United States, 76104
Contact: April Bell       abell01@jpshealth.org   
Principal Investigator: Sandeep Kamath, MD         
Park Plaza Hospital Recruiting
Houston, Texas, United States, 77004
Contact: Joan Morrison       joan.morrison@hcahealthcare.com   
Principal Investigator: Pranav Loyalka, MD         
CHI St. Luke's Health Baylor College of Medicine Med. Ctr. Recruiting
Houston, Texas, United States, 77030
Contact: Melyssa Fink       Melyssa.Fink@bcm.edu   
Principal Investigator: Andrew Civitello, MD         
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Rubi Reyes-Fuentez    713-486-6751    rubi.reyesfuentez@uth.tmc.edu   
Principal Investigator: Sachin Kumar, MD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Deborah Barr    713-441-3916    ddbarr@houstonmethodist.org   
Principal Investigator: Arvind Bhimaraj, MD, MPH         
Methodist Healthcare System of San Antonio Recruiting
San Antonio, Texas, United States, 78201
Contact: Gloria Carreon       gloria.carreon@mhshealth.com   
Principal Investigator: Chandra Kunavarapu, MD         
Methodist Healthcare System of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Gloria Carreon       gloria.carreon@mhshealth.com   
Principal Investigator: Chandra Kunavarapu, MD         
United States, Virginia
Virginia Heart - The Cardiovascular Group, P.C. Recruiting
Falls Church, Virginia, United States, 22042
Contact: Deanna Overbeck       doverbeck@tcg.md   
Principal Investigator: Joseph Kiernan, MD         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant       mmbulliv@sentara.com   
Principal Investigator: David Baran, MD         
Bon Secours Heart & Vascular Institute Recruiting
Richmond, Virginia, United States, 23226
Contact: Janet Barrett       janet_barrett@bshsi.org   
Principal Investigator: Roberta Bogaev, MD         
Winchester Medical Center Recruiting
Winchester, Virginia, United States, 22601
Contact: Shaina Davison       sdavison@valleyhealthlink.com   
Principal Investigator: Nikolas Krishna, MD         
United States, Washington
Providence Everett Medical Center Recruiting
Everett, Washington, United States, 98206
Contact: Rebecca Watson       rebecca.watson@providence.org   
Principal Investigator: Heidi Nicewarner, MD         
Swedish Medical Center - Heart & Vascular Recruiting
Seattle, Washington, United States, 98122
Contact: Charlene Boisjolie    206-215-2455    charlene.boisjolie@Swedish.org   
Principal Investigator: Terrie-Ann Benjamin, MD         
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Greg Mueller       gregm@uw.edu   
Principal Investigator: Gregory Wood, MD         
United States, Wisconsin
Aurora Medical Group Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Marilyn Miller    414-385-2432    marilyn.l.miller@aurora.org   
Principal Investigator: Nasir Sulemanjee, MD         
Waukesha Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Rita Shetty       rita.shetty@phci.org   
Principal Investigator: Matt Weinberg         
Aspirus Wausau Hospital Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Jeff Kaliebe    715-847-2273    jeff.kaliebe@aspirus.org   
Principal Investigator: German Larrain, MD         
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Kim Ronak       kronak@ucalgary.ca   
Principal Investigator: Brian Clarke         
Canada, British Columbia
Vancouver General Hospital (U of BC) Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Jackie Chow       Jackie.Chow@vch.ca   
Principal Investigator: Sean Virani, MD         
Canada, Ontario
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contact: Catherine Mcpherson       cath191@gmail.com   
Principal Investigator: Liane Porepa, MD         
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Natalia Nugaeva, MD       natalia.nugaeva@uhn.ca   
Principal Investigator: Heather Ross, MD         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Director: Poornima Sood, MD, MBA Abbott

Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03387813    
Other Study ID Numbers: CIP-10170
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abbott Medical Devices:
Heart Failure
Hemodynamic Monitoring
CardioMEMS
Pulmonary Artery Pressure
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Failure, Systolic
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases