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Heart FailureCorCinch-PMVINCT03560167

Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

A study testing AccuCinch® Ventricular Restoration System in people with Heart Failure and Cardiomyopathy, Dilated, run by Ancora Heart, Inc. at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Cardiomyopathy, Dilated
What is being tested?
AccuCinch® Ventricular Restoration System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
19 sitesUnited States
Study dates
24 Sep 2018to 28 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Study patient is at least 18-years old
  • Severity of FMR: ≥ Moderate (i.e., ≥2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium1; and 2003 ASE Guidelines for grading mitral regurgitation2)
  • Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment
  • LV Ejection Fraction: ≥20 to ≤40%
  • Symptom Status: NYHA II-IV (i.e., ambulatory)
  • Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and Angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). Treatment shall include CRT and/or ICD when indicated by guidelines.
  • Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

Who cannot join

  • Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)
  • Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
  • Prior surgical, transcatheter, or percutaneous mitral valve replacement
  • Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  • Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
  • Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
Show all 24Show fewer
  • NYHA class IV (i.e., non-ambulatory)
  • Fixed pulmonary artery systolic pressure >70 mmHg
  • Severe tricuspid regurgitation
  • History of stroke within the prior 3 months or any prior stroke with Modified Rankin Scale ≥ 4 disability
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
  • Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system)
  • Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
  • Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
  • Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
  • Active bacterial endocarditis
  • Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
  • Known allergy to nitinol, polyester, or polyethylene
  • 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 the index procedure.
  • Life expectancy < 1 year due to non-cardiac conditions
  • Currently participating in another interventional investigational study
  • Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
  • Subjects on high dose steroids or immunosuppressant therapy
  • Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Piedmont Heart

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30322

  • Austin Heart

    Austin, Texas, 78756

  • University of Virginia School of Medicine

    Charlottesville, Virginia, 22908

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • PinnacleHealth Cardiovascular Institute

    Harrisburg, Pennsylvania, 17101

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Baylor College of Medicine St. Luke's Medical Center

    Houston, Texas, 77020

  • University of Louisville

    Louisville, Kentucky, 40202

  • Minneapolis Heart Foundation Institute

    Minneapolis, Minnesota, 55407

  • Mount Sinai

    New York, New York, 10029

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Virginia Tech Carilion School of Medicine and Research Institute

    Roanoke, Virginia, 24014

  • Intermountain Medical Center

    Salt Lake City, Utah, 84109

  • University of California, San Francisco

    San Francisco, California, 94143

  • University of Washington Medicine

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: An Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study

This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.

Read the detailed description

Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.

Being tested
AccuCinch® Ventricular Restoration System
Medical subject headings
Heart Failure, Cardiomyopathy, Dilated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AccuCinch® Ventricular Restoration SystemDevice

    AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

Study groups in NCT03560167
Study groupRoleWhat they receive
AccuCinch® Ventricular Restoration SystemExperimentalNot described
Receives: Device: AccuCinch® Ventricular Restoration System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety measured by device-related or procedure-related major adverse events (MAEs)

    Device-related or procedure-related major adverse events (MAEs)

    Measured: 30-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start24 Sep 2018
  3. Primary completion25 Mar 2021
  4. Study completion28 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03560167
Sponsor's protocol ID
5018
Acronym
CorCinch-PMVI
Status last verified
Aug 2024
First submitted
6 Jun 2018
Last updated
16 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing AccuCinch® Ventricular Restoration System in people with Heart Failure and Cardiomyopathy, Dilated, run by Ancora Heart, Inc. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety measured by device-related or procedure-related major adverse events (MAEs) (time frame: 30-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03560167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.

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