AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method

Valcare Medical

Status

Completed

Conditions

Mitral Regurgitation

Treatments

Device: AMEND Mitral Valve Repair System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02602613

CL4-0001P

Details and patient eligibility

About

A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient age ≥18
The patient requires mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures
NYHA functional capacity ≥2
The subject is high risk to undergo a mitral valve surgery as assessed by the center heart team
The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits.
The patient is willing to provide Informed consent

Exclusion criteria

Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
Life expectancy of less than twelve months.
Heavily calcified annulus or leaflets.
Previous or active endocarditis.
Active infection.
A previously implanted prosthetic mitral valve or annuloplasty ring/band.
The patient is contraindicated to general anesthesia.
Pregnant (urine HCG test result positive) or lactating patient.
Drug or alcohol abuse.
Participation in concomitant research studies of investigational products that will interfere with the study.