Heart FailureNCT02806570
The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study
A study testing Mitral valve repair in people with Heart Failure and Mitral Valve Insufficiency, run by Ancora Heart, Inc. at 16 sites in United States.
Trial summary
This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies
- What is being tested?
- Mitral valve repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 16 sitesUnited States
- Study dates
- Aug 2016to 22 Aug 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 Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10)
- Ejection Fraction: ≥20 to ≤60%
- Symptom Status: NYHA II-IV (i.e., ambulatory)
- Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month
- Surgical risk: Subject is eligible for cardiac surgery (specific risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team)
- Completion of 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 30 days
- Prior surgical, transcatheter, or percutaneous mitral valve intervention
- 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 16Show fewer
- NYHA class IV (i.e., non-ambulatory) or American College of Cardiology (ACC)/American Heart Association (AHA) Stage D heart failure
- Fixed pulmonary artery systolic pressure >70 mmHg
- Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab)
- 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/constraints preventing appropriate access/implant of the AccuCinch® Ventricular Restoration 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University
Atlanta, Georgia, 30322
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
The Christ Hospital
Cincinnati, Ohio
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, 77020
Nebraska Heart Institute / Nebraska Heart Hospital
Lincoln, Nebraska, 68526
University of Louisville
Louisville, Kentucky, 40202
Minneapolis Heart Foundation Institute
Minneapolis, Minnesota, 55407
NYU Langone Medical Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Carilion Medical Center
Roanoke, Virginia, 24014
Intermountain Medical Center
Salt Lake City, Utah, 84109
University of Washington Medicine
Seattle, Washington, 98195
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Early Feasibility Study of the AccuCinch® Ventricular Restoration System
This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy
Read the detailed description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020
- Conditions
- Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies
- Being tested
- Mitral valve repair
- Medical subject headings
- Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve repairDevice
| Study group | Role | What they receive |
|---|---|---|
| AccuCinch® Ventricular Restoration System | Experimental | Not described Receives: Device: Mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Safety
Assess 30-day safety defined as device-related or procedure-related major adverse events (MAEs).
MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; and heart failure-related hospitalization.
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2020
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ancora Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Zapien, MS, CCRA, Study director, Ancora Heart, Inc. (formerly Guided Delivery Systems Inc.)Dean Kereiakes, MD, Principal investigator, The Christ HospitalSatya Shreenivas, MD, Principal investigator, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806570
- Sponsor's protocol ID
- 4433
- Status last verified
- Jan 2025
- First submitted
- 16 Jun 2016
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the AccuCinch® Ventricular Restoration System
- ClinicalTrials.gov ID
- NCT02806570
- Acronym / sponsor ID
- 4433
- Conditions
- Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ancora Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy
Detailed description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AccuCinch® Ventricular Restoration System | Experimental | Device: Mitral valve repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10)
- Ejection Fraction: ≥20 to ≤60%
- Symptom Status: NYHA II-IV (i.e., ambulatory)
- Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month
Key exclusion criteria (16 listed)
- 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 30 days
- Prior surgical, transcatheter, or percutaneous mitral valve intervention
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve repair | Device | AccuCinch® Ventricular Restoration System |
Primary outcome
30-Day Safety
Time frame: 30-day
Assess 30-day safety defined as device-related or procedure-related major adverse events (MAEs). MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; and heart failure-related hospitalization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zapien, MS, CCRA study director
Ancora Heart, Inc. (formerly Guided Delivery Systems Inc.)
Dean Kereiakes, MD principal investigator
The Christ Hospital
Satya Shreenivas, MD principal investigator
The Christ Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral valve repair in people with Heart Failure and Mitral Valve Insufficiency, run by Ancora Heart, Inc. at 16 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 16 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
30-Day Safety (time frame: 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2025.