A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System
- Conditions
- Congestive Heart FailureLeft Ventricular (LV) Systolic Dysfunction
- Interventions
- Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
- Registration Number
- NCT01614652
- Lead Sponsor
- CardioKinetix, Inc
- Brief Summary
Treatment of ischemic heart failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 331
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Parachute Implant and All Appropriate Medical Therapy (AAMT) CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT) -
- Primary Outcome Measures
Name Time Method Death or re-hospitalization for Worsening Heart Failure (WHF) At least 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (68)
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center - Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
University of Southern California (USC)
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Morton Plant Hospital - Heart and Vascular Institute of Florida
🇺🇸Clearwater, Florida, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
Advocate Medical Group - Midwest Heart Foundation
🇺🇸Naperville, Illinois, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
St Joseph Hospital/Kentucky One
🇺🇸Lexington, Kentucky, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
MidMichigan Medical Center
🇺🇸Midland, Michigan, United States
United Heart and Vascular Clinic
🇺🇸Saint Paul, Minnesota, United States
Gates Vascular Institute/Buffalo General Hospital
🇺🇸Buffalo, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Univ. Of Rochester Medical Center
🇺🇸Rochester, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
Ohio Health Research Institute/Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Einstein Healthcare Network Cardiology
🇺🇸Philadelphia, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Texas Heart Institute at St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Inova Heart and Vascular, Fairfax
🇺🇸Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
The Ohio State University
🇺🇸Columbus, Ohio, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Nebraska Heart Hospital
🇺🇸Lincoln, Nebraska, United States
Arizona Heart
🇺🇸Phoenix, Arizona, United States
Florida Hospital Tampa - Pepin Heart Institute
🇺🇸Tampa, Florida, United States
St. Vincent Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
The Christ Hospital Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Prairie Education and Research Cooperative - St. John's Hospital
🇺🇸Springfield, Illinois, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Tennova Healthcare - Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Arkansas Heart
🇺🇸Little Rock, Arkansas, United States
Kootenai Heart Clinics
🇺🇸Coeur d'Alene, Idaho, United States
Saint Thomas West Hospital
🇺🇸Nashville, Tennessee, United States
Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Jewish Hospital/Louisville
🇺🇸Louisville, Kentucky, United States
LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
St. Joseph Mercy-Michigan Heart
🇺🇸Ann Arbor, Michigan, United States
St. Luke's MAHI
🇺🇸Kansas City, Missouri, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States