A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch® System

Ancora Heart, Inc.1 site in 1 country8 target enrollmentOctober 2013

ConditionsFunctional Mitral Regurgitation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Functional Mitral Regurgitation
Sponsor: Ancora Heart, Inc.
Enrollment: 8
Locations: 1
Primary Endpoint: Major adverse cardiac and cardiovascular events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is designed to demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® System to reduce functional mitral regurgitation.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

March 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ancora Heart, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \>18 years
•Subjects with clinically significant mitral regurgitation (MR 2+ and above)
•Ejection Fraction ≥ 25%
•Stable cardiac medical regimen for heart failure for at least 1 month
•Stable NYHA Classification for at least 1 month
•Subject is eligible for cardiac surgery
•The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent

Exclusion Criteria

•Myocardial infarction within 90 days of the intended treatment with the device
•Prior surgical, transcatheter, or percutaneous mitral valve intervention
•Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease
•Hemodynamic instability or the need for emergent surgery
•Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support
•Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
•Echocardiography evidence of primary mitral valve disease causing MR or MS,
•Evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm2
•Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System
•Estimated GFR of \<30ml/min/1.73m2