NCT03183895

Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

Safety and Performance Evaluation of the AccuCinch® Ventricular Restoration System for the Treatment of Heart Failure With or Without Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy - The CorCinch-EU Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Ancora Heart, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

Detailed 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 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.

Conditions

• Heart Failure
• Cardiomyopathies

Interventions

Type	Name	Description
DEVICE	Left ventricular restoration	The AccuCinch® Ventricular Repair System, implanted in the sub-valvular space of the left ventricle, is intended to reduce significant symptomatic mitral regurgitation and reverse left ventricular remodeling due to dilated cardiomyopathy of either ischemic or non-ischemic etiology via percutaneous interventional methods.

Timeline

• Start date: 2019-01-15
• Primary completion: 2026-10-31
• Completion: 2027-12-01
• First posted: 2017-06-12
• Last updated: 2025-01-29

Locations

19 sites across 10 countries: Belarus, Belgium, Czechia, France, Italy, Lithuania, Netherlands, Poland, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study