A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System
NCT ID: NCT01614652
Last Updated: 2017-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
331 participants
INTERVENTIONAL
2012-12-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
All Appropriate Medical Therapy (AAMT)
No interventions assigned to this group
Interventions
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CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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:
Exclusion Criteria
* 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 .
* 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
18 Years
79 Years
ALL
No
Sponsors
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CardioKinetix, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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William T Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Marco A Costa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals
Leslie Saxon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Arizona Heart
Phoenix, Arizona, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Arkansas Heart
Little Rock, Arkansas, United States
University of Southern California (USC)
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Morton Plant Hospital - Heart and Vascular Institute of Florida
Clearwater, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Florida Hospital Tampa - Pepin Heart Institute
Tampa, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Kootenai Heart Clinics
Coeur d'Alene, Idaho, United States
Evanston Hospital
Evanston, Illinois, United States
Advocate Medical Group - Midwest Heart Foundation
Naperville, Illinois, United States
Prairie Education and Research Cooperative - St. John's Hospital
Springfield, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Iowa Heart Center
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
St Joseph Hospital/Kentucky One
Lexington, Kentucky, United States
Jewish Hospital/Louisville
Louisville, Kentucky, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
LSU Health Sciences Center
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
St. Joseph Mercy-Michigan Heart
Ann Arbor, Michigan, United States
MidMichigan Medical Center
Midland, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
St. Luke's MAHI
Kansas City, Missouri, United States
Nebraska Heart Hospital
Lincoln, Nebraska, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Hackensack UMC
Hackensack, New Jersey, United States
Gates Vascular Institute/Buffalo General Hospital
Buffalo, New York, United States
Mount Sinai Medical Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Univ. Of Rochester Medical Center
Rochester, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
The Christ Hospital Lindner Research Center
Cincinnati, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Ohio Health Research Institute/Riverside Methodist Hospital
Columbus, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Einstein Healthcare Network Cardiology
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center - Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States
Saint Thomas West Hospital
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Inova Heart and Vascular, Fairfax
Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
St. Paul's Hospital
Vancouver, British Columbia, Canada
Countries
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References
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Costa MA, Pencina M, Nikolic S, Engels T, Templin B, Abraham WT. The PARACHUTE IV trial design and rationale: percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles. Am Heart J. 2013 Apr;165(4):531-6. doi: 10.1016/j.ahj.2012.12.022. Epub 2013 Feb 19.
Other Identifiers
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VA0956
Identifier Type: -
Identifier Source: org_study_id
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