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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02602613

Enrollment

Registered

2015-11-11

Start date

2015-12-31

Completion date

2018-12-31

Last updated

2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

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.

Interventions

DEVICEAMEND Mitral Valve Repair System

Annuloplasty ring applied in a transcatheter method

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Safety - Freedom from major SAE's at 6 months following procedure	6 months	Freedom from major SAE's at 6 months following procedure

Countries

Belgium, Czechia, Israel, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026