Acquisition of Objective Data During Transapical Neochordae Implantation

Not Applicable

Withdrawn

• Conditions: Mitral Valve Insufficiency; Mitral Regurgitation
• Interventions: Procedure: Chordal tension measurement; Other: Cardiac Magnetic Resonance Imaging (MRI)

• Registration Number: NCT04709042
• Lead Sponsor: Hospices Civils de Lyon

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. 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. 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.

A large consortium involving physicians and scientists has been created to address those questions, and a large national funding has been raised to fulfil our objectives over a 4 years period (SIMR project). The present clinical study is the core of this large project.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-05-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-24
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chordal tension measurement and cardiac Magnetic Resonance Imaging	Chordal tension measurement	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.
Chordal tension measurement and cardiac Magnetic Resonance Imaging	Cardiac Magnetic Resonance Imaging (MRI)	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.

Primary Outcome Measures

Name	Time	Method
Correlate intraoperative chordal tension and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)	12 months after surgery	Correlation between intraoperative chordal tension (measured in mmHg) and postoperative echocardiographic mitral valve repair success (defined as mitral regurgitation (MR) ≤2+)

Secondary Outcome Measures

Name	Time	Method
Number of patients with mitral regurgitation (MR) > 2+	12 months after surgery	Mitral regurgitation is assessed by echocardiographic exam
Duration of procedure in minutes	Day 0	Intraoperative safety is assessed by procedure duration in minutes (defined as skin incision to skin closure)
Number of adverse events (AEs) and serious adverse events (SAEs)	12 months	Post-operative safety is assessed by occurrence of adverse events (AEs) and serious adverse events (SAEs) at each of the follow-up times
Left ventricular volumes and function quantification	3 months after surgery	Left ventricular volumes and function quantification are assessed by Cardiac Magnetic Resonance Imaging (MRI)
Number of left ventricular tissue fibrosis	3 months after surgery	Left ventricular tissue fibrosis are assessed by Cardiac Magnetic Resonance Imaging (MRI)
Number of rehospitalization for heart failure and mitral valve reoperation	12 months after surgery	Freedom from rehospitalization for heart failure and Mitral valve reoperation free survival
New York Heart Association (NYHA) score	12 months after surgery	Change in functional evaluation is assessed by NYHA functional classification of heart failure. It is based on symptom severity and the amount of exertion needed to provoke symptoms. NYHA heart failure classes are as follows : Class I No limitation of physical activity, Class II Slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest, Class III Marked limitation of physical activity, in which less-than-ordinary activity results in fatigue, palpitation, or dyspnea; the person is comfortable at rest and Class IV Inability to carry on any physical activity without discomfort but also symptoms of heart failure at rest, with increased discomfort if any physical activity is undertaken.
The 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)	12 months after surgery	The EQ-5D-3L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Duration of hospitalization	From the end of surgery (Day 0) to discharge from hospital (Day 15)	Post-operative safety is assessed by duration of hospitalization