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

NCT03183895 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 4631
• Study Type: interventional
• Target: 132
• Locations: 9 countries
• Sites: 17

Brief 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

Conditions

Heart Failure; Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

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

  Major adverse event (MAE) where MAE is a composite of the following device- or procedure-related events: A. All-cause mortality B. Stroke C. Life-threatening bleeding (MVARC scale) D. Major vascular complications E. Major cardiac structural complications F. Myocardial infarction or coronary ischemia requiring PCI or CABG G. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h. I. Emergency surgery or re-intervention related to the device or access procedure

  30-day

Secondary Outcomes (6)

• Technical success: Successful access, delivery, and retrieval of AccuCinch System components, successful deployment of the AccuCinch implant without need for unplanned or emergency surgery or re-intervention

  30-day

• Structural performance: Assessment of device integrity

  30-day

• Clinical outcome: Freedom from re-hospitalizations or re-interventions for the underlying condition

  30-day

• Clinical outcome: Improvement in NYHA functional class

  30-day

• Clinical outcome: Improvement in six-minute walk test

  30-day

Interventions

Left ventricular restoration DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Subjects who present with heart failure with or without functional mitral regurgitation due to dilated cardiomyopathy of ischemic or non-ischemic etiology
• For subjects with FMR, severity of FMR: ≥ Moderate 2+
• For subjects without FMR, LVEDD ≥ 55 mm
• Ejection Fraction: ≥20 to ≤40%
• Symptom Status: NYHA II-IVa
• Patients to be considered for the present study will be required to have received all appropriate guidelines-recommended therapies for at least 3 months prior to the enrollment with stable doses of drugs for at least 1 month.
• Surgical risk:
• 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
• Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
• Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment

You may not qualify if:

• Life expectancy \<1 yr due to noncardiac conditions
• NYHA functional class IVb or ACC/AHA stage D heart failure
• Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or nonischemic etiology
• Fixed pulmonary artery systolic pressure \>70 mm Hg
• Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction
• Mitral valve anatomy which may preclude proper device treatment
• Mitral valve area \<4.0 cm2 (if new device therapy may further decrease the mitral orifice area)
• Any prior mitral valve surgery or transcatheter mitral valve procedure
• Stroke or transient ischemic event within 30 days
• Modified Rankin Scale ≥ 4 disability
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
• Untreated clinically significant coronary artery disease requiring revascularization
• Severe symptomatic carotid stenosis (\>70% by ultrasound).
• Myocardial infarction ≤ 30 days

Sponsors & Collaborators

• Ancora Heart, Inc.: lead

Study Sites (19)

Republican Scientific and Practical Centre of Cardiology

Minsk, 220036, Belarus

Location

Onze Lieve Vrouwziekenhuis

Aalst, Aaslt, 9300, Belgium

Location

AZ Sint-Jan Brugge

Bruges, 10800, Belgium

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Pessac (CHU Bordeaux)

Pessac, Avenue Magellen, 33600, France

Location

Hôpital Cardio-Vasculaire Louis Pradel

Bron, 69500, France

Location

Hôpital de La Timone

Marseille, 13005, France

Location

Paris Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Civil de Strasbourg

Strasbourg, 67000, France

Location

Clinique Pasteur

Toulouse, France

Location

IRCCS Policlinico San Donato

Milan, Piazza Edmondo Malan, 1 San Donato Milanese,, 20037, Italy

Location

Maria Cecilia Hospital

Cotignola, Via Madonna Di Genova, 1,, 48033, Italy

Location

Ospedale San Raffaele

Milan, Via Olgettina, 60,, 20132, Italy

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Medical University of Warsaw

Warsaw, 02-097, Poland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Royal Brompton & Harefield NHS Trust

London, Sydney St, Chelsea, London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Zapien, MS, CCRA

  Ancora Heart, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 12, 2017
• Study Start: January 15, 2019
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

IT (3); LI (1); PL (1); FR (6); BE (1); CZ (1); NL (2); CH (1); GB (1)