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

NCT ID: NCT02602613

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-12-31

Brief Summary

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.

Conditions

Mitral Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMEND

Group Type: EXPERIMENTAL

AMEND Mitral Valve Repair System

Intervention Type: DEVICE

Annuloplasty ring applied in a transcatheter method

Interventions

AMEND Mitral Valve Repair System

Annuloplasty ring applied in a transcatheter method

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valcare Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ZNA Middelheim Hospital

Antwerp, , Belgium

Na Homolce Hospital

Prague, , Czechia

Shaare Zedek Medical Center

Jerusalem, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Azienda Ospedaliera Di Padova

Padua, , Italy

Countries

Belgium; Czechia; Israel; Italy

Other Identifiers

CL4-0001P

Identifier Type: -

Identifier Source: org_study_id