The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study
NCT02806570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-01-29
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
Conditions
- Heart Failure
- Mitral Valve Insufficiency
- Cardiomyopathies
Interventions
- DEVICE
-
Mitral valve repair
Sponsors & Collaborators
-
Ancora Heart, Inc.
lead INDUSTRY
Principal Investigators
-
Michael Zapien, MS, CCRA · Ancora Heart, Inc. (formerly Guided Delivery Systems Inc.)
-
Dean Kereiakes, MD · The Christ Hospital
-
Satya Shreenivas, MD · The Christ Hospital
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2020-01-31
- Completion
- 2024-08-22
- FDA Device
- Yes
Countries
- United States
Study Locations
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