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The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Primary Purpose

Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mitral valve repair
Sponsored by
Ancora Heart, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University
  • University of Louisville
  • Minneapolis Heart Foundation Institute
  • Barnes-Jewish Hospital
  • Nebraska Heart Institute / Nebraska Heart Hospital
  • Montefiore Medical Center
  • NYU Langone Medical Center
  • Columbia University Medical Center
  • The Christ Hospital
  • Pinnacle Health Cardiovascular Institute
  • Penn State Health Milton S. Hershey Medical Center
  • Baylor College of Medicine St. Luke's Medical Center
  • Intermountain Medical Center
  • University of Virginia School of Medicine
  • Carilion Medical Center
  • University of Washington Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AccuCinch® Ventricular Restoration System

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2016
Last Updated
July 19, 2023
Sponsor
Ancora Heart, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02806570
Brief Title
The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study
Official Title
Early Feasibility Study of the AccuCinch® Ventricular Restoration System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ancora Heart, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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
Detailed Description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AccuCinch® Ventricular Restoration System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mitral valve repair
Primary Outcome Measure Information:
Title
30-Day Safety
Description
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.
Time Frame
30-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zapien, MS, CCRA
Organizational Affiliation
Ancora Heart, Inc. (formerly Guided Delivery Systems Inc.)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dean Kereiakes, MD
Organizational Affiliation
The Christ Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Satya Shreenivas, MD
Organizational Affiliation
The Christ Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Minneapolis Heart Foundation Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Heart Institute / Nebraska Heart Hospital
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Pinnacle Health Cardiovascular Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Baylor College of Medicine St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77020
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Carilion Medical Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of Washington Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

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