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

This study has been terminated.
(Company is closed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614652
First Posted: June 8, 2012
Last Update Posted: June 23, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
CardioKinetix, Inc
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Enrollment: 331
Study Start Date: December 2012
Study Completion Date: June 2017
Primary Completion Date: June 2017 (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

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.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01614652


  Hide Study Locations
Locations
United States, Arizona
Arizona Heart
Phoenix, Arizona, United States, 85013
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Arkansas Heart
Little Rock, Arkansas, United States, 72211
United States, California
University of Southern California (USC)
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90069
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Florida
Morton Plant Hospital - Heart and Vascular Institute of Florida
Clearwater, Florida, United States, 33756
Delray Medical Center
Delray Beach, Florida, United States, 33444
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Florida Hospital Tampa - Pepin Heart Institute
Tampa, Florida, United States, 33613
United States, Georgia
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
United States, Idaho
Kootenai Heart Clinics
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
Evanston Hospital
Evanston, Illinois, United States, 60201
Advocate Medical Group - Midwest Heart Foundation
Naperville, Illinois, United States, 60566
Prairie Education and Research Cooperative - St. John's Hospital
Springfield, Illinois, United States, 62701
United States, Indiana
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50266
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242-1081
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
St Joseph Hospital/Kentucky One
Lexington, Kentucky, United States, 40504
Jewish Hospital/Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
St. Joseph Mercy-Michigan Heart
Ann Arbor, Michigan, United States, 48197
MidMichigan Medical Center
Midland, Michigan, United States, 48670
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States, 55102
United States, Missouri
St. Luke's MAHI
Kansas City, Missouri, United States, 64111
United States, Nebraska
Nebraska Heart Hospital
Lincoln, Nebraska, United States, 68526
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Hackensack UMC
Hackensack, New Jersey, United States, 07601
United States, New York
Gates Vascular Institute/Buffalo General Hospital
Buffalo, New York, United States, 14203
Mount Sinai Medical Center
New York, New York, United States, 10029
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10065
Univ. Of Rochester Medical Center
Rochester, New York, United States, 14643
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Christ Hospital Lindner Research Center
Cincinnati, Ohio, United States, 45219
University Hospitals
Cleveland, Ohio, United States, 44106
The Ohio State University
Columbus, Ohio, United States, 43210
Ohio Health Research Institute/Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Oklahoma
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17062
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Einstein Healthcare Network Cardiology
Philadelphia, Pennsylvania, United States, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center - Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States, 17043
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
Saint Thomas West Hospital
Nashville, Tennessee, United States, 37205
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78745
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77056
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Inova Heart and Vascular, Fairfax
Falls Church, Virginia, United States, 22042
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6E 1M7
Sponsors and Collaborators
CardioKinetix, Inc
Investigators
Principal Investigator: William T Abraham, MD Ohio State University
Principal Investigator: Marco A Costa, MD, PhD University Hospitals
Principal Investigator: Leslie Saxon, MD University of Southern California
  More Information

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
First Submitted: June 4, 2012
First Posted: June 8, 2012
Last Update Posted: June 23, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases