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Trial record 1 of 1 for:    NCT02806570
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The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

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: NCT02806570
Recruitment Status : Active, not recruiting
First Posted : June 20, 2016
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Ancora Heart, Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Heart Failure Mitral Valve Insufficiency Cardiomyopathies Device: Mitral valve repair Not Applicable

Detailed Description:
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Early Feasibility Study of the AccuCinch® Ventricular Restoration System
Actual Study Start Date : August 2016
Actual Primary Completion Date : January 2020
Estimated Study Completion Date : March 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: AccuCinch® Ventricular Restoration System Device: Mitral valve repair


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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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 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

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 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)
  • 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
Contacts and Locations
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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): NCT02806570


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Minnesota
Minneapolis Heart Foundation Institute
Minneapolis, Minnesota, United States, 55407
United States, Nebraska
Nebraska Heart Institute / Nebraska Heart Hospital
Lincoln, Nebraska, United States, 68526
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
NYU Langone Medical Center
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States
United States, Pennsylvania
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, United States, 17101
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Texas
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, United States, 77020
United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84109
United States, Virginia
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908
Carilion Medical Center
Roanoke, Virginia, United States, 24014
United States, Washington
University of Washington Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Ancora Heart, Inc.
Investigators
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Study Director: Michael Zapien, MS, CCRA Ancora Heart, Inc. (formerly Guided Delivery Systems Inc.)
Principal Investigator: Dean Kereiakes, MD The Christ Hospital
Principal Investigator: Satya Shreenivas, MD The Christ Hospital
More Information
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Responsible Party: Ancora Heart, Inc.
ClinicalTrials.gov Identifier: NCT02806570    
Other Study ID Numbers: 4433
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021

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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
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases