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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: AMEND Mitral Valve Repair System

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
    • ZNA Middelheim Hospital
• Czechia
  • Prague, Czechia, 15030
    • Na Homolce Hospital
• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center
• Italy
  • Padova, Italy
    • Azienda Ospedaliera di Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMEND	Device: AMEND Mitral Valve Repair System; Annuloplasty ring applied in a transcatheter method

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Valcare Medical Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CL4-0001P