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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03560167
Other study ID # 5018
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 24, 2018
Est. completion date December 30, 2024

Study information

Verified date April 2023
Source Ancora Heart, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.


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Study Design


Intervention

Device:
AccuCinch® Ventricular Restoration System
AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

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Sponsors (1)

Lead Sponsor Collaborator
Ancora Heart, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety measured by device-related or procedure-related major adverse events (MAEs) Device-related or procedure-related major adverse events (MAEs) 30-day
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