heart failure major infarction
Conditions
Interventions
Implantation of the CardioKinetics Parachute Device. Implantation occurs
through heart catheterization through the arteria femorali.s
Device described in Chapter 5.4 of the protocol
Sponsors
CardioKinetix Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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% and* 40% as measured by echocardiography. * Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography. * 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
Exclusion criteria
Exclusion criteria: * Untreated clinically significant coronary artery disease requiring intervention. * Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment * Cardiogenic shock within 72 hours of enrollment * Revascularization procedure (PCI or CABG) within 60 days of enrollment * Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment * History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF * Aortic valve replacement or repair * Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states. * Active peptic ulcer or GI bleeding within the past 3 months * Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months * History of Kawasaki*s disease * Ongoing sepsis, including active endocarditis. * Anatomical characteristics not suitable for treatment with the Parachute Implant device as screened by the echocardiography core lab. (characteristics include inappropriate size and shape of the left ventricle, presence of LV apical thrombus, pseudo chordae or trabeculations)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of long term safety as measured by site-reported procedural and device related MACE in real world use of the Parachute Implant through 5 years of clinical follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months, and annually through 5 years. Change in exercise tolerance from baseline to 6 and 12 month follow-up as measured by 6-Minute Walk Test. Number of and time to the combined cardiovascular mortality and morbidity that includes all cause death, hospitalization for heart failure, myocardial infarction, and stroke, whichever is earlier, within 6, and 12 months from the date of implantation of the study device | — |
Countries
Netherlands
Outcome results
None listed