Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02624960

Safety and Performance of the AccuCinch® System

Safety and Performance of the AccuCinch® Ventricular Repair System

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Ancora Heart, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral regurgitation in symptomatic adult patients with mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.

Conditions

Interventions

TypeNameDescription
DEVICEAccucinch ImplantPercutaneous implantation of the Accucinch Implant in the mitral subannular space

Timeline

Start date
2016-09-01
Primary completion
2019-03-01
Completion
2019-09-01
First posted
2015-12-09
Last updated
2018-07-27

Source: ClinicalTrials.gov record NCT02624960. Inclusion in this directory is not an endorsement.