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A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by CardioKinetix, Inc
Sponsor:
Information provided by (Responsible Party):
CardioKinetix, Inc
ClinicalTrials.gov Identifier:
NCT01614652
First received: June 4, 2012
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

Treatment of ischemic heart failure.


Condition Intervention Phase
Congestive Heart Failure
Left Ventricular (LV) Systolic Dysfunction
Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Resource links provided by NLM:


Further study details as provided by CardioKinetix, Inc:

Primary Outcome Measures:
  • Death or re-hospitalization for Worsening Heart Failure (WHF) [ Time Frame: At least 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 560
Study Start Date: December 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parachute Implant and All Appropriate Medical Therapy (AAMT) Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
No Intervention: All Appropriate Medical Therapy (AAMT)

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Candidates for this study must meet ALL of the following inclusion criteria:

Clinical Inclusion Criteria:

  • Age ≥ 18 and ≤ 79 years.
  • Body Mass Index (BMI) ≤ 40.
  • Symptomatic ischemic heart failure (New York Heart Association (NYHA) Class III or "ambulatory" Class IV as determined through the use of the SAS) post Myocardial Infarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days prior to enrollment.
  • Patient is not hospitalized at the time of enrollment.
  • Receiving appropriate medical treatment for heart failure according to the current American College of Cardiology (ACC)/American Heart Association (AHA) Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment.
  • The patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
  • The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

Inclusion Criteria based on Imaging:

  • 15% ≤ Left Ventricular Ejection Fraction (LVEF) ≤ 35% by Transthoracic Echocardiogram (TTE).
  • Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by TTE.
  • Left ventricle must have appropriate anatomy (size and morphology) for implant placement using Cardiac Computed Tomography (CT) and confirmed by LV gram

Candidates will be excluded from the study if ANY of the following conditions apply:

Clinical Exclusion Criteria:

  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Cardiogenic shock within 72 hours of enrollment.
  • Patient has received a pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) within 60 days of enrollment.
  • Excessive wall motion abnormalities outside the anteroapical region.
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • End stage renal disease requiring chronic dialysis.
  • Obstructive Sleep Apnea (OSA): unless compliant on CPAP therapy or successful surgery.
  • Hemoglobin < 10 g/dl (female), < 12 g/dl (male) or Creatinine > 2.5mg/dl.
  • Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  • Active peptic ulcer or GI bleeding within the past 3 months.
  • A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre-medicated.
  • Ongoing sepsis, including active endocarditis.
  • Life expectancy < 1 year due to associated non-cardiac co-morbid conditions or currently on the heart transplant lists.
  • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from appropriate consent.
  • Currently participating in an investigational drug or another device study (prior to primary endpoint reached).
  • Female patients with childbearing potential and a positive urine pregnancy test .

Anatomical Exclusion Criteria:

  • Pre-existing prosthetic heart valve in mitral or aortic position.
  • Valvular stenosis or regurgitation (tricuspid, aortic or mitral) > 2+.
  • Presence of anatomic anomalies (including severe calcification) detected by cardiac imaging (echocardiogram, Computed Tomography (CT), or LV gram) preventing unimpeded deployment and/or operation of the Parachute Implant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614652

Contacts
Contact: Richelle Massey, MBA 650-364-7016 ext 434 rmassey@cardiokinetix.com

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Medical Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Deborah Strootman    520-400-3223    dstrootman@shc.arizona.edu   
Principal Investigator: Ranjith Shetty, MD         
Principal Investigator: Mark Friedman, MD         
United States, Arkansas
Arkansas Heart Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Teresa Dunegan    501-748-8408    teresa.dunegan@arheart.com   
Principal Investigator: Carl J. Leding, MD         
Principal Investigator: David M. Mego, MD         
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90069
Contact: Mane Arabyan    310-248-8515    mane.arabyan@cshs.org   
Principal Investigator: Saibal Kar, MD         
Principal Investigator: Jon Kobashigawa, MD         
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Kimberley Book    916-734-5639    kimberley.book@ucdmc.ucdavis.edu   
Principal Investigator: Jason Rogers, MD         
Principal Investigator: Kathleen Tong, MD         
United States, Florida
Morton Plant Hospital - Heart and Vascular Institute of Florida Recruiting
Clearwater, Florida, United States, 33756
Contact: Kathleen Swan    727-489-2556    kswan@havi-north.com   
Principal Investigator: Patrick Cambier, MD         
Tallahassee Research Institute Recruiting
Tallahassee, Florida, United States, 32308
Contact: Patty Knap    850-431-5024    patty.knap@tmh.org   
Principal Investigator: Wayne Batchelor, MD         
Principal Investigator: Akash Ghai, MD         
Florida Hospital Tampa - Pepin Heart Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Cynthia Paysor    813-615-7527    cynthia.paysor@ahss.org   
Principal Investigator: Charles R Lambert, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Beth Holloway    404-712-7665    beth.holloway@emory.edu   
Principal Investigator: Kreton Mavromatis, MD         
Principal Investigator: Divya Gupta, MD         
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Jennifer Ro    443-204-3523    jcro@emory.edu   
Sub-Investigator: Gautam Kumar, MD         
United States, Idaho
Kootenai Heart Clinics Recruiting
Coeur d'Alene, Idaho, United States, 83814
Contact: Shamela Barnett    208-676-9913 ext 638    SBarnett@kh.org   
Principal Investigator: Ronald D Jenkins, MD         
Principal Investigator: Timothy J Lessmeier, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Anna Huskin    312-695-4067    ahuskin@nmh.org   
Principal Investigator: Charles Davidson, MD         
Principal Investigator: Allen Anderson, MD         
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Jean Skelskey    847-570-1810    jskelskey@northshore.org   
Principal Investigator: Ted Feldman, MD         
Principal Investigator: Steve Smart, MD         
Advocate Medical Group - Midwest Heart Foundation Recruiting
Naperville, Illinois, United States, 60566
Contact: Joan Yanz    630-873-3405    joan.yanz@advocatehealth.com   
Principal Investigator: Mark Goodwin, MD         
Principal Investigator: Maria Rosa Costanzo, MD         
Prairie Education and Research Cooperative Recruiting
Springfield, Illinois, United States, 62701
Contact: Amy Kavanagh    217-492-9100 ext 146    AKavanagh@prairieresearch.com   
Principal Investigator: Jeff Goldstein, MD         
Principal Investigator: Mark Stampehl, MD         
United States, Indiana
St. Vincent Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Jill Gall    317-583-6304    jmgall@stvincent.org   
Principal Investigator: James Hermiller, MD         
Principal Investigator: Mary Walsh, MD         
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50266
Contact: Michelle Fopma    515-235-5114    mfopma@iowaheart.com   
Principal Investigator: Mark Tannenbaum, MD         
Principal Investigator: William Wickemeyer, MD         
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242-1081
Contact: Page Scovel    319-384-8005    page-scovel@uiowa.edu   
Principal Investigator: Phillip Horwitz, MD         
Principal Investigator: Vladimir Cotarlan, MD         
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Deanna K. Benoit    985-873-5613    Deanna.Benoit@cardio.com   
Principal Investigator: Peter Fail, MD         
Principal Investigator: Richard Abben, MD         
LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Cris Molina    504-568-2349    cmoli1@lsuhsc.edu   
Principal Investigator: Frank Smart, MD         
Principal Investigator: Murtuza J. Ali, MD         
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Cristine Hardy    504-842-6832    chardy@ochsner.org   
Principal Investigator: J. Stephen Jenkins, MD         
Principal Investigator: Hector Ventura, MD         
United States, Michigan
St. Joseph Mercy-Michigan Heart Recruiting
Ann Arbor, Michigan, United States, 48197
Contact: Kristy Wippler    734-712-7602    kwippler@MichiganHeart.com   
Principal Investigator: Marlo F. Leonen, MD         
Principal Investigator: Arthur M. Szyniszewski, MD         
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Emily Caldwell    612-626-3656    caldw076@umn.edu   
Principal Investigator: Gladwin Suseekar Das, MD         
Principal Investigator: Emil D Missov, MD         
United Heart and Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Brian Halverson    651-241-2817    Brian.Halverson@allina.com   
Principal Investigator: Bilal Murad, MD         
Principal Investigator: Alan Bank, MD         
United States, Missouri
St. Luke's MAHI Recruiting
Kansas City, Missouri, United States, 64111
Contact: Kimberlyn Behnke    816-932-0391    kbehnke@saint-lukes.org   
Principal Investigator: Andrew Kao, MD         
Mercy Hospital St. Louis Recruiting
St. Louis, Missouri, United States, 63141
Contact: Nicole Elmore    314-251-3922    nicole.elmore@mercy.net   
Principal Investigator: Anthony Sonn, MD         
Principal Investigator: Bruce Czarnik, MD         
United States, New Jersey
Deborah Heart and Lung Center Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Lisa Cruser    609-893-6611 ext 5028    CruserL@Deborah.org   
Principal Investigator: Jon George, MD         
Principal Investigator: David Hsi, MD         
United States, New York
Gates Vascular Institute Recruiting
Buffalo, New York, United States, 14203
Contact: Elizabeth Hejna    716-835-2966    ehejna@buffaloheartgroup.com   
Principal Investigator: A.R. Zaki Masud, MD         
Principal Investigator: Marie A. Iacona, MD         
New York Presbyterian Hospital - Cornell Campus Recruiting
New York, New York, United States, 10065
Contact: Madeline Yushak    212-746-2698    yushakm@nyp.org   
Principal Investigator: S. Chiu Wong, MD         
Principal Investigator: Evelyn Horn, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Hugo Bloise    212-241-8228    hugo.bloise-adames@mountsinai.org   
Principal Investigator: George Dangas, MD         
Principal Investigator: Sean Pinney, MD         
Lenox Hill Hospital North Shore Recruiting
New York, New York, United States, 10075
Contact: Melissa Ricketts    212-434-3934    melissa.ricketts@gmail.com   
Principal Investigator: Carlos Ruiz, MD         
Principal Investigator: Sandeep Jauhar, MD         
United States, Ohio
The Christ Hospital Lindner Research Center Recruiting
Cincinnatti, Ohio, United States, 45219
Contact: Christine Huber    513-585-1723    LindnerTrials@TheChristHospital.com   
Principal Investigator: Eugene Chung, MD         
Principal Investigator: Dean Kereiakes, MD         
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nadine Norton    216-844-2636    nadine.norton@uhhospitals.org   
Principal Investigator: Daniel Simon, MD         
Principal Investigator: Guilherme H Oliveira, MD         
Ohio Health Research Institute/Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Martha Slyman    614-566-1274    martha.slyman@ohiohealth.com   
Principal Investigator: Lee W. Jordan, MD         
Principal Investigator: Steven J. Yakubov, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Shawna Oxier    614-247-6797    shawna.oxier@osumc.edu   
Principal Investigator: Ernest Mazzaferri, MD         
Principal Investigator: Garrie J Haas, MD         
United States, Oklahoma
Integris Baptist Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Miki Thompson    405-951-2894    miki.thompson@integrisok.com   
Principal Investigator: George Chrysant, MD         
Principal Investigator: Douglas Horstmanshof, MD         
Oklahoma Heart Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Lisa Sumner    405-608-1290    lsumner@okheart.com   
Principal Investigator: Philip Adamson, MD         
Principal Investigator: John M. Williams, MD         
United States, Pennsylvania
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17062
Contact: Heidi Testa    717-544-1777    hltesta@lghealth.org   
Principal Investigator: Roy S. Small, MD         
Principal Investigator: Rupal P. Dumasia, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Judi A. Willhide    212-662-2245    judi.willhide@uphs.upenn.edu   
Principal Investigator: Joyce W. Wald, MD         
Principal Investigator: Howard C. Herrmann, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Kenneth Rayl    412-359-6860    kray@wpahs.org   
Principal Investigator: Dave Lasorda, MD         
Principal Investigator: Srinivas Murali, MD         
University of Pittsburgh Medical Center - Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Laurie Dennis    412-647-6210    papugall@upmc.edu   
Principal Investigator: Catalin Toma, MD         
Principal Investigator: Marc Simon, MD         
Pinnacle Health Cardiovascular Institute Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Gretchen Meise, RN    717-920-4400 ext 4280    gMeise@pinnaclehealth.org   
Principal Investigator: Brijeshwar Maini, MD         
Principal Investigator: David Pawlush, MD         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Catherine Gordon    401-793-4105    cgordon@lifespan.org   
Principal Investigator: Paul Gordon, MD         
Principal Investigator: Daniel Levine, MD         
United States, Tennessee
Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Terrie Walker    423-230-5643    twalker@mycva.com   
Principal Investigator: Rahul Sakhuja, MD         
Principal Investigator: Sandeep Jauhar, MD         
Tennova Healthcare - Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Contact: Linda Doughty    865-218-7539    linda.doughty@hma.com   
Principal Investigator: Malcolm T. Foster, MD         
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Carol Meisch    615-343-4983    carol.meisch@vanderbilt.edu   
Principal Investigator: Daniel Lenihan, MD         
Principal Investigator: Robert Piana, MD         
Saint Thomas West Hospital Recruiting
Nashville, Tennessee, United States, 37205
Contact: Mitzi Baker    615-222-3815    mbaker@sth.org   
Principal Investigator: Andrew Morse, MD         
Principal Investigator: Don Chomsky, MD         
United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Nazanin Zarinkamar    713-500-7575    nazanin.zarinkamar@uth.tmc.edu   
Principal Investigator: Bijwajit Kar, MD         
Principal Investigator: Sriram Nathan, MD         
Texas Heart Institute at St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Contact: James Chen    832-355-9366    jchen@texasheart.org   
Principal Investigator: Emerson Perin, MD         
Principal Investigator: Andrew Civitello, MD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77056
Contact: Patricia Brinegar    713-363-7995    pbrinegar@HoustonMethodist.org   
Principal Investigator: Neal S. Kleiman, MD         
Principal Investigator: Jerry Estep, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Ashlee Rooks    801-585-7295    Ashlee.Rooks@hsc.utah.edu   
Principal Investigator: James Fang, MD         
Principal Investigator: Anwar Tandar, MD         
United States, Virginia
Inova Heart and Vascular, Fairfax Recruiting
Falls Church, Virginia, United States, 22042
Contact: Stacey Banks    703-776-2302    stacey.banks@inova.org   
Principal Investigator: Shahram Yazdani, MD         
Principal Investigator: Shashank Desai, MD         
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Tina Calayo    757-388-1568    cawolszc@sentara.com   
Principal Investigator: Allen Ciuffo, MD         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Melissa Sears    804-828-1601    mlsears@vcu.edu   
Principal Investigator: Zachary Gertz, MD         
Principal Investigator: Keyur Shah, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Deb Tinlin    206-215-2455    deborah.tinlin@swedish.org   
Principal Investigator: Paul Huang, MD         
Principal Investigator: Oana Petrescu, MD         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Maggie Miller    414-385-1853    maggie.miller@aurora.org   
Principal Investigator: Suhail Allaqaband, MD         
Principal Investigator: Nasir Sulemanjee, MD         
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Contact: Lenka Miklosova    604-806-8804    lmiklosova@providencehealth.bc.ca   
Principal Investigator: John Webb, MD         
Principal Investigator: Mustafa Toma, MD         
Sponsors and Collaborators
CardioKinetix, Inc
Investigators
Principal Investigator: William T Abraham, MD Ohio State University
Principal Investigator: Marco A Costa, MD, PhD University Hospitals
  More Information

No publications provided by CardioKinetix, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CardioKinetix, Inc
ClinicalTrials.gov Identifier: NCT01614652     History of Changes
Other Study ID Numbers: VA0956
Study First Received: June 4, 2012
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by CardioKinetix, Inc:
Congestive Heart Failure Due to LV Systolic Dysfunction

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 24, 2014