NCT02602613

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 3, 2019

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

November 9, 2015

Last Update Submit

May 1, 2019

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Safety - Freedom from major SAE's at 6 months following procedure

    6 months

Study Arms (1)

AMEND

EXPERIMENTAL
Device: AMEND Mitral Valve Repair System

Interventions

AMEND Mitral Valve Repair SystemDEVICE

Annuloplasty ring applied in a transcatheter method

AMEND

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

ZNA Middelheim Hospital

Antwerp, 2020, Belgium

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Azienda Ospedaliera Di Padova

Padua, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 11, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 3, 2019

Record last verified: 2017-10

Locations

IT(1)CZ(1)IL(2)BE(1)