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

January 28, 2025 updated by: Ancora Heart, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220036
        • Republican Scientific and Practical Centre of Cardiology
  • Belgium
      • Brugge, Belgium, 10800
        • AZ Sint-Jan Brugge
    • Aaslt
      • Aalst, Aaslt, Belgium, 9300
        • Onze Lieve Vrouwziekenhuis
  • Czechia
      • Prague, Czechia, 15030
        • Na Homolce Hospital
  • France
      • Bron, France, 69500
        • Hopital Cardio-vasculaire Louis Pradel
      • Marseille, France, 13005
        • Hopital de la Timone
      • Paris, France, 75013
        • Paris Hôpital de la Pitié-Salpêtrière
      • Strasbourg, France, 67000
        • Hôpital Civil de Strasbourg
      • Toulouse, France
        • Clinique Pasteur
    • Avenue Magellen
      • Pessac, Avenue Magellen, France, 33600
        • Pessac (CHU Bordeaux)
  • Italy
    • Piazza Edmondo Malan, 1 San Donato Milanese,
      • Milano, Piazza Edmondo Malan, 1 San Donato Milanese,, Italy, 20037
        • IRCCS Policlinico San Donato
    • Via Madonna Di Genova, 1,
      • Cotignola, Via Madonna Di Genova, 1,, Italy, 48033
        • Maria Cecilia Hospital
    • Via Olgettina, 60,
      • Milano, Via Olgettina, 60,, Italy, 20132
        • Ospedale San Raffaele
  • Lithuania
      • Vilnius, Lithuania, 08661
        • Vilnius University Hospital Santaros Klinikos
  • Netherlands
      • Nieuwegein, Netherlands
        • St. Antonius ziekenhuis
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medical Center
  • Poland
      • Warsaw, Poland, 02-097
        • Medical University of Warsaw
  • Switzerland
      • Zürich, Switzerland, 8091
        • University Hospital Zurich
  • United Kingdom
    • Sydney St, Chelsea, London
      • London, Sydney St, Chelsea, London, United Kingdom, SW3 6NP
        • Royal Brompton & Harefield NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

    1. For subjects with FMR, severity of FMR: ≥ Moderate 2+
    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:

    1. 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)
    2. 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

Exclusion Criteria:

  • 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
  • Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
  • Tricuspid valve disease requiring surgery or severe tricuspid regurgitation (per ASE guidelines; core lab assessment)
  • Aortic valve disease requiring surgery
  • Moderate or severe aortic valve stenosis or regurgitation
  • Aortic valve prosthesis
  • Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus, or vegetation
  • Need for any cardiovascular surgery (other than for MV disease)
  • Active endocarditis
  • Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch System (e.g., femoral arteries will not support an 20F system)
  • Known allergy to nickel, polyester, or polyethylene
  • Active infections requiring current antibiotic therapy
  • Subjects in whom transesophageal echocardiography is contraindicated
  • Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
  • Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
  • Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to procedure.
  • Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 1 month
  • Absence of CRT with class I indication criteria for biventricular pacing (left bundle branch block pattern and QRS duration ≥150 ms)
  • Subjects on high dose steroids or immunosuppressant therapy
  • Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits
  • Patient is unable or unwilling to sign written patient information sheet and informed consent form before study enrollment. This study excludes vulnerable populations as defined in protocol section 18.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety outcome: 30-day major adverse events (MAEs)
Time Frame: 30-day

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 30-day
Successful access, delivery, and retrieval of all AccuCinch catheters. Deployment and correct positioning of the intended AccuCinch implant, and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure measured upon completion of the procedure.
30-day
Structural performance: Assessment of device integrity
Time Frame: 30-day
No migration, embolization, detachment, fracture, hemolysis, thrombosis or endocarditis; and no para-device complications (erosion, effusion requiring surgery or drainage or producing tamponade, damage to the MV apparatus)
30-day
Clinical outcome: Freedom from re-hospitalizations or re-interventions for the underlying condition
Time Frame: 30-day
Freedom from re-hospitalizations or re-interventions for the underlying condition
30-day
Clinical outcome: Improvement in NYHA functional class
Time Frame: 30-day
Improvement in NYHA functional class when compared to baseline assessment
30-day
Clinical outcome: Improvement in six-minute walk test
Time Frame: 30-day
Improvement in six-minute walk test (6MWT) when compared to baseline assessment
30-day
Clinical outcome: Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL)
Time Frame: 30-day
Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) when compared to baseline
30-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ancora Heart, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Zapien, MS, CCRA, Ancora Heart, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4631

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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