Mitral Regurgitation Clinical Trial
Official title:
Acquisition of Objective Data During Transapical Neochordae Implantation
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03278574 -
Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease
|
N/A | |
| Suspended |
NCT04960280 -
A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease
|
N/A | |
| Recruiting |
NCT05021614 -
Valveclip® Transcatheter Mitral Valve Repair Study
|
N/A | |
| Not yet recruiting |
NCT06167213 -
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
|
N/A | |
| Not yet recruiting |
NCT06465745 -
AltaValve Pivotal Trial
|
N/A | |
| Withdrawn |
NCT05040451 -
Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
|
||
| Withdrawn |
NCT03714412 -
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System
|
N/A | |
| Recruiting |
NCT02592889 -
(MitraClip in Non-Responders to Cardiac Resynchronization Therapy)
|
Phase 4 | |
| Completed |
NCT02355418 -
The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
|
||
| Not yet recruiting |
NCT01431222 -
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
|
Phase 4 | |
| Completed |
NCT01841554 -
Cardioband With Transfemoral Delivery System
|
N/A | |
| Not yet recruiting |
NCT03870516 -
Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery
|
N/A | |
| Active, not recruiting |
NCT03230747 -
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
|
N/A | |
| Enrolling by invitation |
NCT04031274 -
Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
|
||
| Completed |
NCT05836532 -
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
|
||
| Completed |
NCT05850026 -
Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
|
||
| Completed |
NCT05836480 -
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
|
||
| Recruiting |
NCT03975998 -
Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
|
||
| Completed |
NCT01162083 -
Identifying an Ideal Cardiopulmonary Exercise Test Parameter
|
N/A | |
| Suspended |
NCT00787293 -
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
|
Phase 2 |