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Cardiovascular DiseasesMITRACHORDNCT02829749

Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse

A study testing NeoChord beating heart mitral valve implantation in people with Cardiovascular Diseases, run by Hospices Civils de Lyon at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
NeoChord beating heart mitral valve implantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
Jun 2020to Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Louis Pradel

    Bron

Other trials in France

About this study

Official title: A European, Multicenter, Randomized Study Comparing the Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse

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.

Being tested
NeoChord beating heart mitral valve implantation, Control
Keywords
Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency
Medical subject headings
Cardiovascular Diseases, Heart Valve Diseases, Heart Failure, Heart Diseases, Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • ControlProcedure or surgery

    traditional mitral valve repair performed under cardiac arrest

Study groups in NCT02829749
Study groupRoleWhat they receive
NeoChord DS1000 Artificial Chordae Delivery SystemExperimentalSubjects randomized to the experimental group will undergo the NeoChord implantation
Receives: Device: NeoChord beating heart mitral valve implantation
ControlOthertraditional mitral valve repair performed under cardiac arrest
Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (9)

  1. Proportion of patients with any major adverse events

    Major adverse events defined by death all cause, Post-operative myocardial infarction, Reoperation for failed surgical repair or valve replacement, Any reoperation or intervention for adverse events (Bleeding…), stoke, renal failure, wound infection, septicemia, ventilation > 24 hours, transfusion ≥ 2 units

    Measured: 30 days

  2. Overall survival

    Measured: 12 months

  3. Mitral valve reoperation free survival

    Measured: 12 months

  4. mitral regurgitation > 2+

    Measured: 12 months

  5. Freedom from rehospitalization for heart failure

    Measured: 12 months

  6. Change in functional evaluation (NYHA)

    Measured: 12 months

  7. Change in functional evaluation (6 minute walk test )

    Measured: 12 months

  8. Change in quality of life score

    by using the EQ-5D questionnaire ( European Quality of Life-5 Dimensions) instrument

    Measured: 12 months

  9. Number of device success

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2016 (estimated)
  2. Study startJun 2020 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionOct 2022 (estimated)

Why it stopped: Because of dynamics in the field of minimal invasive mitral repair and the development of newer devices

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02829749
Sponsor's protocol ID
69HCL16_0115
Other IDs
IDRCB
Acronym
MITRACHORD
Status last verified
Jan 2020
First submitted
4 Jul 2016
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NeoChord beating heart mitral valve implantation in people with Cardiovascular Diseases, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined incidence of Death from any cause, redo surgery for valve dysfunction, and moderate-severe (3+) or severe (4+) mitral regurgitation (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02829749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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