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

Study Overview
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Brief Summary
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Treatment of ischemic heart failure.

Official Title
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Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Conditions
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Congestive Heart Failure, Left Ventricular (LV) Systolic Dysfunction

Intervention / Treatment
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* Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parachute Implant and All Appropriate Medical Therapy (AAMT)<br> | Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)<br>* CardioKinetix Parachute implant and all appropriate medical therapy<br>|
| No Intervention: All Appropriate Medical Therapy (AAMT)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or re-hospitalization for Worsening Heart Failure (WHF) |  | At least 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure Due to LV Systolic Dysfunction