A Placebo Controlled, Multicenter, Randomized Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Myocardial Infarction
- Sponsor
- Bellerophon BCM LLC
- Enrollment
- 303
- Locations
- 82
- Primary Endpoint
- Left Ventricular End Diastolic Volume Index
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).
Detailed Description
Heart failure is a significant problem, and carries substantial mortality. According to studies, left ventricular (LV) remodeling contributes independently to heart failure progression. Prevention and reversal of LV remodeling are correlated with decreased risk of death and heart failure events. IK-5001 is an implantable device to be used in subjects with recent myocardial infarction (MI). The IK-5001 device has been shown to directly halt the remodeling process that occurs following acute MI. IK-5001 replaces the damaged extracellular matrix (ECM) that has degraded during infarction, supports the damaged myocardial tissue, prevents local dyskinesis, and decreases wall stress. Because of its minimal interaction with the myocardium, its mechanism of action, its lack of specific pharmacologic activity and its elimination behavior, IK-5001 is a medical device in concurrence with the Global Harmonization Task Force's harmonized definition for medical devices.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Left Ventricular End Diastolic Volume Index
Time Frame: Baseline, 6 Months
Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.
Secondary Outcomes
- Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations(5 Years)
- Kansas City Cardiomyopathy Questionaire(Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits)
- Six minute walk test(Baseline (prior to discharge STEMI), 1, 3, 6 and 12 month follow-up visits)
- New York Heart Association (NYHA) functional classification (Physician reported)(Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits)
- Re-hospitalization due to any cardiovascular event(5 Years)