Active — Not RecruitingNot Applicable

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

Belarus, Belgium, Czechia132 participantsStarted 2019-01-15

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. For subjects with FMR, severity of FMR: ≥ Moderate 2+
✓. For subjects without FMR, LVEDD ≥ 55 mm
✓. For patients with FMR only: the Heart Team must assess as high-risk and may utilize risk score or comorbidities to demonstrate high risk features. High risk for mitral valve surgery is defined utilizing 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) (MVARC Part 1)
✓. For all patients: Subject is eligible for cardiac surgery (namely, the patient is in a condition that allows a potential conversion to open surgery in case of procedural complications). This criterion adds a safety level for the patients

What they're measuring

Safety outcome: 30-day major adverse events (MAEs)

Timeframe: 30-day

Trial details

NCT IDNCT03183895

SponsorAncora Heart, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-31

View on ClinicalTrials.gov More Heart Failure trials