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

Last updated: June 21, 2017
Sponsor: CardioKinetix, Inc
Overall Status: Terminated

Phase

3

Condition

Chest Pain

Heart Disease

Congestive Heart Failure

Treatment

CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)

Clinical Study ID

NCT01614652
VA0956
  • Ages 18-79
  • All Genders

Study Summary

Treatment of ischemic heart failure.

Eligibility Criteria

Inclusion

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 MyocardialInfarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days priorto enrollment.

  • Patient is not hospitalized at the time of enrollment.

  • Receiving appropriate medical treatment for heart failure according to the currentAmerican College of Cardiology (ACC)/American Heart Association (AHA) Guideline Updatefor the Diagnosis and Management of Chronic Heart Failure in the Adult during thethree months prior to enrollment.

  • The patient or the patient's legal representative has been informed of the nature ofthe study, agrees to its provisions, and has provided written informed consent asapproved by the Institutional Review Board (IRB)/Ethics Committee (EC) of therespective clinical site.

  • The patient and the treating physician agree that the patient will return for allrequired 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 implantplacement using Cardiac Computed Tomography (CT) and confirmed by LV gram Candidates will be excluded from the study if ANY of the following conditions apply:

Exclusion

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), orCardiac 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 hypercoagulablestates.

  • Active peptic ulcer or GI bleeding within the past 3 months.

  • A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titaniumand nickel alloy), or sensitivity to contrast media, which cannot be adequatelypre-medicated.

  • Ongoing sepsis, including active endocarditis.

  • Life expectancy < 1 year due to associated non-cardiac co-morbid conditions orcurrently on the heart transplant lists.

  • Other medical, social, or psychological conditions that in the opinion of anInvestigator precludes the patient from appropriate consent.

  • Currently participating in an investigational drug or another device study (prior toprimary 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 cardiacimaging (echocardiogram, Computed Tomography (CT), or LV gram) preventing unimpededdeployment and/or operation of the Parachute Implant

Study Design

Total Participants: 331
Treatment Group(s): 1
Primary Treatment: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
Phase: 3
Study Start date:
December 01, 2012
Estimated Completion Date:
June 30, 2017

Connect with a study center

  • St. Paul's Hospital

    Vancouver, British Columbia V6E 1M7
    Canada

    Site Not Available

  • Arizona Heart

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • University of Arizona Medical Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Arkansas Heart

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90069
    United States

    Site Not Available

  • University of Southern California (USC)

    Los Angeles, California 90033
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Morton Plant Hospital - Heart and Vascular Institute of Florida

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Delray Medical Center

    Delray Beach, Florida 33444
    United States

    Site Not Available

  • Tallahassee Research Institute

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Florida Hospital Tampa - Pepin Heart Institute

    Tampa, Florida 33613
    United States

    Site Not Available

  • Piedmont Atlanta Hospital

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Kootenai Heart Clinics

    Coeur d'Alene, Idaho 83814
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Evanston Hospital

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Advocate Medical Group - Midwest Heart Foundation

    Naperville, Illinois 60566
    United States

    Site Not Available

  • Prairie Education and Research Cooperative - St. John's Hospital

    Springfield, Illinois 62701
    United States

    Site Not Available

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Iowa Heart Center

    Des Moines, Iowa 50266
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242-1081
    United States

    Site Not Available

  • University of Kansas Hospital

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • St Joseph Hospital/Kentucky One

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Jewish Hospital/Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Cardiovascular Institute of the South

    Houma, Louisiana 70360
    United States

    Site Not Available

  • LSU Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • St. Joseph Mercy-Michigan Heart

    Ann Arbor, Michigan 48197
    United States

    Site Not Available

  • MidMichigan Medical Center

    Midland, Michigan 48670
    United States

    Site Not Available

  • University of Minnesota Medical Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • United Heart and Vascular Clinic

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • St. Luke's MAHI

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Mercy Hospital St. Louis

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Nebraska Heart Hospital

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey 08015
    United States

    Site Not Available

  • Hackensack UMC

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Gates Vascular Institute/Buffalo General Hospital

    Buffalo, New York 14203
    United States

    Site Not Available

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York 10065
    United States

    Site Not Available

  • Univ. Of Rochester Medical Center

    Rochester, New York 14643
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • The Christ Hospital Lindner Research Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Christ Hospital Lindner Research Center

    Cincinnatti, Ohio 45219
    United States

    Site Not Available

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio Health Research Institute/Riverside Methodist Hospital

    Columbus, Ohio 43214
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17062
    United States

    Site Not Available

  • Einstein Healthcare Network Cardiology

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburg Medical Center - Presbyterian Hospital

    Pittsburg, Pennsylvania 15213
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • University of Pittsburgh Medical Center - Presbyterian Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Pinnacle Health Cardiovascular Institute

    Wormleysburg, Pennsylvania 17043
    United States

    Site Not Available

  • The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee 37934
    United States

    Site Not Available

  • Saint Thomas West Hospital

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78745
    United States

    Site Not Available

  • Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Heart Institute at St. Luke's Episcopal Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • The Methodist Hospital

    Houston, Texas 77056
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Inova Heart and Vascular, Fairfax

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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