Percutaneous Ventricular Restoration in Chronic Heart Failure due to Ischemic Heart Disease

Completed

Conditions: 10019280
apical aneurysm
chronic heart failure

Registration Number: NL-OMON36701

Lead Sponsor: CardioKinetix Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Akinesis or dyskinesis due to previous myocardial infarction limited to anteroapical region.
Patient is not hospitalized at time of enrollment.
Diagnosis of heart failure for a minimum of 6 months prior to enrollment
NYHA Class III or IV .
Post LV myocardial infarction structural heart dysfunction represented by LV wall motion abnormality by echocardiography.
LVEF >15% and * 40% as measured by echocardiography.
Between 18 and 79 years of age.
Receiving appropriate medical treatment for heart failure.

Exclusion Criteria

Untreated clinically significant coronary artery disease requiring intervention.
Acute myocardial infarction or revascularization procedure (PCI or CABG) within 60 days of enrollment.
Cardiogenic shock within 72 hours of enrollment.
Contraindication for asparin and anticoagulation therapy.
Moderate aortic stenosis and regurgitation >2+.
Aortic valve replacement or repair.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assessment of safety defined as the successful delivery and deployment of the<br /><br>Parachute Implant through 6-month follow-up without the occurrence of Major<br /><br>Adverse Cardiac Events (MACE) related to the investigational device.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End<br /><br>Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months.<br /><br><br /><br>Change in exercise tolerance from baseline to 6 and 12 month follow-up as<br /><br>measured by 6-Minute Walk Test.<br /><br>Combined cardiovascular mortality and morbidity that includes all cause death,<br /><br>hospitalization for heart failure, myocardial infarction and stroke from<br /><br>baseline to 6, and 12 months.</p><br>