Phase
Condition
Chest Pain
Heart Disease
Congestive Heart Failure
Treatment
CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
Clinical Study ID
Ages 18-79 All Genders
Study Summary
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
Connect with a study center
St. Paul's Hospital
Vancouver, British Columbia V6E 1M7
CanadaSite Not Available
Arizona Heart
Phoenix, Arizona 85013
United StatesSite Not Available
University of Arizona Medical Center
Tucson, Arizona 85724
United StatesSite Not Available
Arkansas Heart
Little Rock, Arkansas 72211
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90069
United StatesSite Not Available
University of Southern California (USC)
Los Angeles, California 90033
United StatesSite Not Available
UC Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
Yale-New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Morton Plant Hospital - Heart and Vascular Institute of Florida
Clearwater, Florida 33756
United StatesSite Not Available
Delray Medical Center
Delray Beach, Florida 33444
United StatesSite Not Available
Tallahassee Research Institute
Tallahassee, Florida 32308
United StatesSite Not Available
Florida Hospital Tampa - Pepin Heart Institute
Tampa, Florida 33613
United StatesSite Not Available
Piedmont Atlanta Hospital
Atlanta, Georgia 30309
United StatesSite Not Available
Kootenai Heart Clinics
Coeur d'Alene, Idaho 83814
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Evanston Hospital
Evanston, Illinois 60201
United StatesSite Not Available
Advocate Medical Group - Midwest Heart Foundation
Naperville, Illinois 60566
United StatesSite Not Available
Prairie Education and Research Cooperative - St. John's Hospital
Springfield, Illinois 62701
United StatesSite Not Available
St. Vincent Heart Center of Indiana
Indianapolis, Indiana 46260
United StatesSite Not Available
Iowa Heart Center
Des Moines, Iowa 50266
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242-1081
United StatesSite Not Available
University of Kansas Hospital
Kansas City, Kansas 66160
United StatesSite Not Available
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesSite Not Available
St Joseph Hospital/Kentucky One
Lexington, Kentucky 40504
United StatesSite Not Available
Jewish Hospital/Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Cardiovascular Institute of the South
Houma, Louisiana 70360
United StatesSite Not Available
LSU Health Sciences Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
St. Joseph Mercy-Michigan Heart
Ann Arbor, Michigan 48197
United StatesSite Not Available
MidMichigan Medical Center
Midland, Michigan 48670
United StatesSite Not Available
University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United StatesSite Not Available
United Heart and Vascular Clinic
Saint Paul, Minnesota 55102
United StatesSite Not Available
St. Luke's MAHI
Kansas City, Missouri 64111
United StatesSite Not Available
Mercy Hospital St. Louis
St. Louis, Missouri 63141
United StatesSite Not Available
Nebraska Heart Hospital
Lincoln, Nebraska 68526
United StatesSite Not Available
Deborah Heart and Lung Center
Browns Mills, New Jersey 08015
United StatesSite Not Available
Hackensack UMC
Hackensack, New Jersey 07601
United StatesSite Not Available
Morristown Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
Gates Vascular Institute/Buffalo General Hospital
Buffalo, New York 14203
United StatesSite Not Available
Mount Sinai Medical Center
New York, New York 10029
United StatesSite Not Available
New York Presbyterian Hospital - Cornell Campus
New York, New York 10065
United StatesSite Not Available
Univ. Of Rochester Medical Center
Rochester, New York 14643
United StatesSite Not Available
Wake Forest Baptist Health
Winston-Salem, North Carolina 27157
United StatesSite Not Available
The Christ Hospital Lindner Research Center
Cincinnati, Ohio 45219
United StatesSite Not Available
The Christ Hospital Lindner Research Center
Cincinnatti, Ohio 45219
United StatesSite Not Available
University Hospitals
Cleveland, Ohio 44106
United StatesSite Not Available
Ohio Health Research Institute/Riverside Methodist Hospital
Columbus, Ohio 43214
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Lancaster General Hospital
Lancaster, Pennsylvania 17062
United StatesSite Not Available
Einstein Healthcare Network Cardiology
Philadelphia, Pennsylvania 19141
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburg Medical Center - Presbyterian Hospital
Pittsburg, Pennsylvania 15213
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
University of Pittsburgh Medical Center - Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania 17043
United StatesSite Not Available
The Miriam Hospital
Providence, Rhode Island 02906
United StatesSite Not Available
Wellmont Holston Valley Medical Center
Kingsport, Tennessee 37660
United StatesSite Not Available
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee 37934
United StatesSite Not Available
Saint Thomas West Hospital
Nashville, Tennessee 37205
United StatesSite Not Available
Vanderbilt University
Nashville, Tennessee 37232
United StatesSite Not Available
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78745
United StatesSite Not Available
Memorial Hermann Hospital
Houston, Texas 77030
United StatesSite Not Available
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas 77030
United StatesSite Not Available
The Methodist Hospital
Houston, Texas 77056
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84132
United StatesSite Not Available
Inova Heart and Vascular, Fairfax
Falls Church, Virginia 22042
United StatesSite Not Available
Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
United StatesSite Not Available
Virginia Commonwealth University Medical Center
Richmond, Virginia 23298
United StatesSite Not Available
Swedish Medical Center
Seattle, Washington 98122
United StatesSite Not Available
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available
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