Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Cardiomyopathies
- Heart Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary objectives of this study are to evaluate the safety and performance of the AccuCinch Ventricular Repair System for the treatment of heart failure and functional mitral regurgitation in symptomatic adult patients with or without functional mitral regurgitation (FMR) and left ventricular r...
The primary objectives of this study are to evaluate the safety and performance of the AccuCinch Ventricular Repair System for the treatment of heart failure and functional mitral regurgitation in symptomatic adult patients with or without functional mitral regurgitation (FMR) and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who remain symptomatic despite optimized medical therapy. Subjects with FMR must present with at least moderate FMR, a reduced ejection fraction (?40%) and high operative risk as assessed by the Heart Team. The Heart Team may utilize established risk scores (STS, Euro-Score II) in conjunction with comorbidities as recommended by MVARC (frailty index; major organ system compromise not to be improved postoperatively; procedure specific impediments). Subjects without FMR must present a markedly dilated left ventricle with LVEDD ? 55 mm and reduced ejection fraction (?40%). These patients are not potential candidates for "conventional intervention", because their mitral valve is not in need of repair or replacement. Therefore, AccuCinch represents the sole treatment option for these patients, who are not selected on the basis of high surgical risk.
Tracking Information
- NCT #
- NCT03183895
- Collaborators
- Not Provided
- Investigators
- Study Director: Michael Zapien, MS, CCRA Ancora Heart, Inc.