A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System
A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System
Treatment of ischemic heart failure.
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