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

The CORCINCH-HF Study

An evaluation of the AccuCinch Ventricular Restoration System in patients who have symptomatic heart failure with reduced ejection fraction (HFrEF).

Study Overview

• Design: Prospective, randomized, open-label, multi-center, international clinical safety and efficacy investigation.
• Randomization: Treatment with AccuCinch System plus guideline-directed medical therapy (GDMT) or GMDT alone.
• Enrollment: 400 subjects

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

• Ejection Fraction ≥20% and ≤40%
• New York Heart Association (NYHA) Classification:
  • NYHA II (with a heart failure hospitalization in the past 12 months)
  • NYHA III
  • NYHA IV (ambulatory)
• LV end-diastolic diameter of ≥55mm
• Guideline-directed medical therapy for at least three months (stable doses for one month)

ClinicalTrials.gov Identifier: NCT04331769