NCT04709042

Brief Summary

Mitral Valve repair (MVr) is the gold standard treatment for primary Mitral Regurgitation. Implantation of artificial Gore-Tex chordae (or neochordae implantation) is often used for MVr. The NeoChord DS1000 (NeoChord Inc., Minneapolis, USA) is a device designed to deploy neochordae through transapical access in a beating heart and without cardiopulmonary bypass. NeoChord System is CE marked and therefore authorized for use in Europe. Procedure is conducted under 3D transesophageal echocardiography (TEE) guidance. The device is introduced through the apex of the left ventricular (LV) and the prolapsed leaflet is grabbed and harpooned. The neochordae are thus stretched between the valve and the LV apex. Neochordae length can be precisely adapted to restore a normal coaptation, to treat the regurgitation. Recently, the principal investigator's teams (heart surgery department at Hospices Civils de Lyon and Laboratoire de Génie Electrique et Ferromagnétique lab at Institut National des Sciences Appliquées (INSA) de Lyon, France) created a platform allowing the measurement of the tension applied on neochordae during a NeoChord procedure. A dedicated protocol was designed and approved by the ethical committee of the French Society of Cardiology. The measurement was performed in 7 patients. This preliminary study shows that the technic is safe. It also suggests that chordal tension might be correlated to the quality of MVr: the sub-valvular apparatus appears to be in a low stress state when the structure and the function of the valve are restored. These first findings raise new questions:

  1. 1.The mechanism involved in the changes in tensions during chordal length adjustment cannot be understood with current standard medical imaging tools. Numerical simulation technologies could bring physical data in order to approach physical phenomenon underlying these findings.
  2. 2.Novel chordal tension measurement tools could lead to a change in current paradigm enabling a MVr based on objective data measurement, instead of sole morphological analysis. Prognostic value of chordal tension must be studied through a larger clinical study and a systematic protocol.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2021

Typical duration for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

January 11, 2021

Last Update Submit

March 9, 2022

Conditions

Mitral Valve InsufficiencyMitral Regurgitation

Keywords

Primary Mitral RegurgitationMitral Valve repairHeart SurgeryNeochord DS1000Intraoperative Chordal TensionTension MeasurementCardiac Magnetic Resonance ImagingPostoperative echocardiographic evaluation

Outcome Measures

Primary Outcomes (3)

  • Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)

    Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)

    Day 0

  • Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)

    Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)

    1 month after surgery

  • Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)

    Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)

    12 months after surgery

Secondary Outcomes (22)

  • Duration of procedure in minutes

    Day 0

  • Number of adverse events (AEs) and serious adverse events (SAEs)

    12 months

  • Duration of hospitalization

    From the end of surgery (Day 0) to discharge from hospital (Day 15)

  • Number of patients with mitral regurgitation (MR) > 2+

    1 month after surgery

  • Number of patients with mitral regurgitation (MR) > 2+

    12 months after surgery

  • +17 more secondary outcomes

Study Arms (1)

Chordal tension measurement and cardiac Magnetic Resonance Imaging

EXPERIMENTAL

All patient candidates for NeoChord implantation according to the standard of care will be considered for inclusion in this clinical study. Chordal tension measurement will be performed during Neochord implantation. Moreover, all patients will undergo cardiac Magnetic Resonance Imaging (MRI) exam before the surgery, as well as at 3 months follow-up.

Procedure: Chordal tension measurementOther: Cardiac Magnetic Resonance Imaging (MRI)

Interventions

Chordal tension measurementPROCEDURE

The chordal tension measurement will be performed during surgery. The neochordae are connected to the measuring device through "crocodile" clips (e.g. machine-patient interface).We start to apply traction on the chordae that is in the center of the flailing area thanks to a millimeter screw and under TEE control. After obtaining a stable tension (plateau value), the other chordae are then tracked, one at a time, with an individual screw. When we achieve an equivalent tension on all chordae, a traction on all chordae is applied thanks to the principal screw under TEE control until obtaining a perfect coaptation. When the correction is optimal (good echocardiographic result, chordal tension low and equally spread on each chordae), the measurements are then stopped, and the chordae are fixed at the apex of the left ventricle at the optimal length.

Chordal tension measurement and cardiac Magnetic Resonance Imaging
Cardiac Magnetic Resonance Imaging (MRI)OTHER

Patients will undergo 2 MRI exams: 1 MRI before surgical intervention (maximum 21 days before) and 1 MRI three months after surgery (+/- 14 days), with intravenous administration of gadolinium.

Chordal tension measurement and cardiac Magnetic Resonance Imaging

Eligibility Criteria

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

You may qualify if:

  • Adults (≥ 18 years old)
  • Patient candidate for NeoChord procedure after validation by the local Heart-Team
  • severe symptomatic MR due to a posterior prolapses, involving mainly the P2 segment (with a variable extension on P1 or P3, but never involving the commissures or the anterior leaflet). Also, a LAI (leaflet to annulus index) \>1,25 will be required.
  • and considered as high-risk for conventional surgery (mainly because of frailty) after selection by our heart team.
  • Patient who has provided his written informed consent to participate in the study
  • Patient affiliated to a social health insurance.

You may not qualify if:

  • Patient with contraindication for NeoChord technic including:
  • Patient with secondary MR
  • LV dilatation with initial tethering
  • Central component to regurgitant jet
  • Calcified leaflets segments.
  • Patient with contraindication for Cardiovascular Magnetic Resonance (CMR) imaging:
  • Patients without sinus rhythm
  • Regular MRI contraindications (e.g. a pacemaker, defibrillator or metallic (ferromagnetic) body, a known allergy to gadolinium)
  • Contraindication for Gadolinium infusion : glomerular filtration rate (GFR) \<30 ml / min
  • Patient unable to understand the purpose of the study
  • Patient participating in another trial that would interfere with this study
  • Female patient who is pregnant or lactating
  • Patients under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Grinberg D, Cottinet PJ, Thivolet S, Audigier D, Capsal JF, Le MQ, Obadia JF. Measuring chordae tension during transapical neochordae implantation: Toward understanding objective consequences of mitral valve repair. J Thorac Cardiovasc Surg. 2019 Sep;158(3):746-755. doi: 10.1016/j.jtcvs.2018.10.029. Epub 2018 Oct 17.

    PMID: 30454983RESULT

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Daniel GRINBERG, MD

    Hôpital Pneumologique et Cardiovasculaire Louis Pradel

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 14, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

March 24, 2022

Record last verified: 2022-03