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The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Sponsor
Ancora Heart, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02806570
Collaborator
(none)
35
Enrollment
16
Locations
1
Arm
91
Anticipated Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Mitral valve repair
 N/A

Detailed Description

Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020

Study Design

Study Type:
Interventional
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 :
Aug 1, 2016
Actual Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: AccuCinch® Ventricular Restoration System

Device: Mitral valve repair

Outcome Measures

Primary Outcome Measures

  1. 30-Day Safety [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Emory University Atlanta Georgia United States 30322
2 University of Louisville Louisville Kentucky United States 40202
3 Minneapolis Heart Foundation Institute Minneapolis Minnesota United States 55407
4 Nebraska Heart Institute / Nebraska Heart Hospital Lincoln Nebraska United States 68526
5 Hackensack University Medical Center Hackensack New Jersey United States 07601
6 Montefiore Medical Center Bronx New York United States 10467
7 NYU Langone Medical Center New York New York United States 10016
8 Columbia University Medical Center New York New York United States 10032
9 The Christ Hospital Cincinnati Ohio United States
10 Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania United States 17101
11 Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
12 Baylor College of Medicine St. Luke's Medical Center Houston Texas United States 77020
13 Intermountain Medical Center Salt Lake City Utah United States 84109
14 University of Virginia School of Medicine Charlottesville Virginia United States 22908
15 Carilion Medical Center Roanoke Virginia United States 24014
16 University of Washington Medicine Seattle Washington United States 98195

Sponsors and Collaborators

  • Ancora Heart, Inc.

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ancora Heart, Inc.
ClinicalTrials.gov Identifier:
NCT02806570
Other Study ID Numbers:
  • 4433
First Posted:
Jun 20, 2016
Last Update Posted:
Aug 2, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Cardiomyopathies
Mitral Valve Insufficiency

Study Results

No Results Posted as of Aug 2, 2021