A Multinational Trial to Evaluate the Longterm Safety of the Parachute Implant System (PARACHUTEIII)
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The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.
Condition or disease
Heart FailureMyocardial Infarction
While current therapies for heart failure (including but not limited to: medical management, cardiac resynchronization and ICDs) may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device. The purpose of this study is to assess the longterm safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of the left ventricle in patients with symptoms of HF due to ischemic heart disease.
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Ages Eligible for Study:
18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study population will be open to all individuals who meet the inclusion/exclusion criteria. This is a prospective, multi-center, non-randomized trial.
Candidates for this study must meet ALL of the following inclusion criteria:
Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
Subject is not hospitalized at time of enrollment.
NYHA Class at time of enrollment, either:
NYHA Class III or Ambulatory IV - if predominant during the 3-month period prior to enrollment
NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment
LVEF >15 or% and ≤ 40% as measured by echocardiography.
Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
Eligible for cardiac surgery
Between 18 and 79 years of age (inclusive)
Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2009 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
Provide written informed consent
Agree to the protocol-required follow-up
Candidates will be excluded from the study if ANY of the following conditions apply: