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

Not Applicable

Completed

• Conditions: Mitral Regurgitation
• Interventions: Device: AMEND Mitral Valve Repair System

• Registration Number: NCT02602613
• Lead Sponsor: Valcare Medical Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Study Start: 2015-12
• Status Verified: 2017-10
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMEND	AMEND Mitral Valve Repair System	-

Primary Outcome Measures

Name	Time	Method
Safety - Freedom from major SAE's at 30 days following procedure	30 days	Freedom from major SAE's at 30 days following procedure
Technical success of implantation	End of procedure	Ring location and attachment based on echocardiography

Secondary Outcome Measures

Name	Time	Method
Safety - Freedom from major SAE's at 6 months following procedure	6 months	Freedom from major SAE's at 6 months following procedure

Trial Locations

Locations (5)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel

ZNA Middelheim Hospital; 🇧🇪 Antwerpen, Belgium

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Azienda Ospedaliera Di Padova; 🇮🇹 Padova, Italy