CORCINCH-EU

The CORCINCH-EU Study

An evaluation of the AccuCinch® Ventricular Restoration System for the treatment of heart failure in patients with or without functional mitral regurgitation (FMR) due to dilated ischemic or non-ischemic cardiomyopathy.

Study Overview

• Design: Prospective, non-randomized, single-arm, international, multicenter clinical safety and performance investigation.
• Randomization: Treatment with AccuCinch System plus guideline-directed medical therapy (GDMT)
• Enrollment: 132 subjects

To be eligible, patients must meet the following main criteria:

• Ejection Fraction ≥20% and ≤40%
• New York Heart Association (NYHA) Classification:
  • NYHA II
  • NYHA III
  • NYHA IV (ambulatory)
• LV end-diastolic diameter of ≥55 mm (when MR < Moderate 2+)

ClinicalTrials.gov Identifier: NCT03183895