Trial record 1 of 1 for:
NCT03560167
Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation (CorCinch-PMVI)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03560167 |
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Recruitment Status :
Active, not recruiting
First Posted : June 18, 2018
Last Update Posted : July 28, 2021
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Sponsor:
Ancora Heart, Inc.
Information provided by (Responsible Party):
Ancora Heart, Inc.
- Study Details
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure Cardiomyopathy, Dilated | Device: AccuCinch® Ventricular Restoration System | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Device Feasibility |
| 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 |
| Actual Study Start Date : | September 24, 2018 |
| Actual Primary Completion Date : | March 25, 2021 |
| Estimated Study Completion Date : | December 30, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: AccuCinch® Ventricular Restoration System |
Device: AccuCinch® Ventricular Restoration System
AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation |
Primary Outcome Measures :
- Safety measured by device-related or procedure-related major adverse events (MAEs) [ Time Frame: 30-day ]Device-related or procedure-related major adverse events (MAEs)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560167
Locations
Show 19 study locations
Sponsors and Collaborators
Ancora Heart, Inc.
Investigators
| Study Director: | Michael Zapien, MS, CCRA | Ancora Heart, Inc. | |
| Principal Investigator: | Kendra Grubb, MD | Emory University | |
| Principal Investigator: | Guilherme Silva, MD | Baylor / St. Luke's Medical Center |
| Responsible Party: | Ancora Heart, Inc. |
| ClinicalTrials.gov Identifier: | NCT03560167 |
| Other Study ID Numbers: |
5018 |
| First Posted: | June 18, 2018 Key Record Dates |
| Last Update Posted: | July 28, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Additional relevant MeSH terms:
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Cardiomyopathies Mitral Valve Insufficiency Cardiomyopathy, Dilated Heart Diseases Cardiovascular Diseases |
Heart Valve Diseases Cardiomegaly Laminopathies Genetic Diseases, Inborn |