NCT02829749

Brief Summary

The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
3.9 years until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

July 4, 2016

Last Update Submit

January 8, 2020

Conditions

Cardiovascular Diseases

Keywords

Heart Valve DiseasesHeart failureHeart diseasesMitral valve insufficiency

Outcome Measures

Primary Outcomes (1)

  • Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation

    1 year

Secondary Outcomes (9)

  • Proportion of patients with any major adverse events

    30 days

  • Overall survival

    12 months

  • Mitral valve reoperation free survival

    12 months

  • mitral regurgitation > 2+

    12 months

  • Freedom from rehospitalization for heart failure

    12 months

  • +4 more secondary outcomes

Study Arms (2)

NeoChord DS1000 Artificial Chordae Delivery System

EXPERIMENTAL

Subjects randomized to the experimental group will undergo the NeoChord implantation

Device: NeoChord beating heart mitral valve implantation

Control

OTHER

traditional mitral valve repair performed under cardiac arrest

Procedure: Control

Interventions

NeoChord beating heart mitral valve implantationDEVICE

The NeoChord DS1000 procedure is performed in five steps: (1) Device Preparation; (2) Left Ventricular Access; (3) Leaflet Capture and Verification; (4) Suture Deployment and (5) Suture Closure. The sutures are placed via a ventriculotomy 2-4 cm postero-lateral from the apex of the left ventricle via thoracotomy. The procedure is performed on a beating heart through a 2 to 3 inch right antero-lateral thoracotomy, then one to five Goretex neochordae are introduced with a transcatheter delivery system through the apex of the heart, into the left ventricle, and fixed on the free edge of the prolapsed leaflet. This is performed with transesophageal echocardiographic guidance.

NeoChord DS1000 Artificial Chordae Delivery System
ControlPROCEDURE

traditional mitral valve repair performed under cardiac arrest

Control

Eligibility Criteria

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

You may qualify if:

  • Severe primary mitral regurgitation (grade 3+ or 4+)
  • Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines:
  • Symptomatic patients and/or
  • LV (Left Ventricular) dysfunction : LVESD ≥45 mm and/or 30≤ LVEF ≤60%
  • Leaflet prolapse of P2 and/or A2
  • Predicted coaptation length \> 4 mm
  • Candidates for surgical mitral valve repair according to heart team
  • Patient able to sign an informed consent form
  • Patient benefiting from a social insurance system or a similar system

You may not qualify if:

  • Asymptomatic patients with preserved LV function
  • Complex mechanism of MR (leaflet perforation, severe calcifications, commissural extension, etc)
  • Secondary MR
  • Predicted post-repair coaptation length less than 4 mm
  • Atrial fibrillation
  • Inflammatory or infective valve disease
  • Severe LV dilation (DTD \> 65 mm)
  • Significant mitral annulus dilatation (D \> 45 mm)
  • Surgical indication of tricuspid annulus
  • Contraindication to TEE (transesophageal echocardiographic ) or inadequate image quality
  • Need for any other concomitant cardiac procedure
  • Concurrent medical condition with a life expectancy of less than 24 months
  • Patient unable to understand the purpose of the trial
  • Patient \< 18 years old
  • Participation to another trial that would interfere with this trial
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Pradel

Bron, France

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Valve DiseasesHeart FailureHeart DiseasesMitral Valve Insufficiency

Study Officials

  • Jean-François OBADIA, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 12, 2016

Study Start

June 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)