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Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™ (Intellect2)

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ClinicalTrials.gov Identifier: NCT03247829
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions

Condition or disease Intervention/treatment
Heart Failure Device: Hemodynamic management using CardioMEMS

Detailed Description:

The study is an observational, single group study where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as standard of care. After enrollment into the study, the patient will be followed until six month follow up completion. The objective of this clinical investigation is to understand the role of hemodynamic monitoring in LVAD patients and:

  • Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients under different clinical and physiologic conditions
  • Characterize the effects of PA pressure on functional status, quality of life, and hospital readmissions of LVAD patients
  • Evaluate target ranges for PA pressure and assess the impact of medication and pump speed changes on PA pressures

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure
Actual Study Start Date : August 17, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Patients with CardioMEMS and LVAD
Patients with CardioMEMS and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS
Device: Hemodynamic management using CardioMEMS
Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges




Primary Outcome Measures :
  1. Six Minute Hall Walk (6MHW) distance [ Time Frame: six months ]
    Change in 6MHW distance


Other Outcome Measures:
  1. CardioMEMS PA pressure over time [ Time Frame: six months ]
    Changes in PA pressure measurement over time

  2. Days PA pressure is in the pre-specified target range [ Time Frame: six months ]
    Percentage of days PA pressure is in the pre-specified target range

  3. PA pressure before 6MHW test to after 6MHW test [ Time Frame: six months ]
    Changes in PA pressure before 6MHW test to after 6MHW test

  4. CardioMEMS and HeartMate Device malfunctions [ Time Frame: six months ]
    Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD

  5. New York Heart Association (NYHA) classification [ Time Frame: six months ]
    NYHA classification at baseline and each scheduled follow-up visit

  6. EQ-5D-5L [ Time Frame: six months ]
    Health related quality of life (EQ-5D-5L)

  7. All-cause hospitalizations [ Time Frame: six months ]
    All-cause hospitalization rate

  8. Worsening heart failure events [ Time Frame: six months ]
    Heart failure hospitalization rate including emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management

  9. 6MHW distance by PA pressure ranges [ Time Frame: six months ]
    Change in 6MHW distance by various PA pressure ranges

  10. NYHA class by PA pressure ranges [ Time Frame: six months ]
    Change in NYHA class by various PA pressure ranges

  11. EQ-5D-5L by PA pressure ranges [ Time Frame: six months ]
    Change in EQ-5D-5L by various PA pressure ranges

  12. All cause hospitalization rate by PA pressure ranges [ Time Frame: six months ]
    All cause hospitalization rate by various PA pressure ranges



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart Failure patients will be recruited from the clinicians practice based on the presence of both devices under study
Criteria

Inclusion Criteria:

  1. Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS sensor must be implanted within 72 hours of consent (Group B)
  2. Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
  3. No connectivity or transmission problems with CardioMEMS
  4. On HeartMate LVAD support for at least 3 months
  5. Age ≥ 18 years

Exclusion Criteria:

  1. Current participation in an investigation that is likely to confound study results or affect study outcome
  2. Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial
  3. Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)

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): NCT03247829


Contacts
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Contact: Stella Osuji 972-526-9644 stella.osuji@abbott.com

Locations
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United States, California
Scripps Health Recruiting
La Jolla, California, United States, 92037
Contact: Janet Daniel    858-216-7370    daniel.janet@scripphealth.org   
Principal Investigator: Thomas Heywood, MD         
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Melissa Ramos    323-442-7283    melissa.ramos@med.usc.edu   
Principal Investigator: Andrew Yoon, MD         
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Sandra Rodriguez    301-794-4794    sarodriguez@mednet.ucla.edu   
Principal Investigator: Ali Nsair, MD         
San Diego Cardiac Recruiting
San Diego, California, United States, 92123
Contact: Chris Kohlmyer    858-244-6886    ckohlmyer@sdcardiac.com   
Principal Investigator: Brian Jaske, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Traci Parks    319-353-5236    Traci-parks@uiowa.edu   
Principal Investigator: Jay Bhama, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Rebekah Evans    859-323-8663    rebekah.evans@uky.edu   
Principal Investigator: Maya Guglin, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Gina Paciotti    612-625-0920    gpaciott@umn.edu   
Principal Investigator: Rebecca Cogswell, MD         
United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: Taelyr Miller    402-559-5127    tjmiller@unmc.edu   
Principal Investigator: Adam Burdorf, MD         
United States, North Carolina
University of North Carolina Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Tyrone Wade    919-962-4896    tyrone_wade@med.unc.edu   
Principal Investigator: Christopher Chien, MD         
WakeMed Hospital Recruiting
Winston-Salem, North Carolina, United States, 27610
Contact: Rhonda Norton    919-350-2243    rnorton@wakemed.org   
Principal Investigator: Priyesh Patel, MD         
United States, Ohio
Ohio Sate University Recruiting
Columbus, Ohio, United States, 43210
Contact: Neha Mali    614-688-5506    neha.mali@osumc.edu   
Principal Investigator: Sitaramesh Emani, MD         
United States, Oregon
Providence Heart and Vascular Institute Recruiting
Portland, Oregon, United States, 97225
Contact: Sarah Grant    503-216-7370    sarah.grant@providence.org   
Principal Investigator: Jacob Abraham, MD         
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Mohamad Ghosn    713-441-9837    mghosn@houstonmethodist.org   
Principal Investigator: Arvind Bhimaraj, MD         
United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: John Kirk    801-585-2340    john.kirk@hsc.utah.edu   
Principal Investigator: Stavros Drakos, MD         
United States, Wisconsin
Aurora Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Cherly Zywicki    414-385-2474    cheryl.zywicki@aurora.org   
Principal Investigator: Nasir Sulemanjee, MD         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Poornima Sood Abbott

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03247829     History of Changes
Other Study ID Numbers: SJM-CIP-10178
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abbott Medical Devices:
CardioMEMS
Left Ventricular Assist Device
Hemodynamic Management

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases