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

Mitral Regurgitation Clinical Trial

Official title:

AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602613
• Other study ID #: CL4-0001P
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: Valcare Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• AMEND Mitral Valve Repair System
Annuloplasty ring applied in a transcatheter method

Locations

Country	Name	City	State
Belgium	ZNA Middelheim Hospital	Antwerpen
Czechia	Na Homolce Hospital	Prague
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Sheba Medical Center	Ramat Gan
Italy	Azienda Ospedaliera Di Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Valcare Medical Ltd.

Countries where clinical trial is conducted

Belgium,  Czechia,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Freedom from major SAE's at 30 days following procedure	Freedom from major SAE's at 30 days following procedure	30 days
Primary	Technical success of implantation	Ring location and attachment based on echocardiography	End of procedure
Secondary	Safety - Freedom from major SAE's at 6 months following procedure	Freedom from major SAE's at 6 months following procedure	6 months