Mitral Valve Prolapse Clinical Trial
Official title:
A Randomized Trial of Mitral Valve Repair With Leaflet Resection Versus Leaflet Preservation on Functional Mitral Stenosis: The Canadian Mitral Research Alliance (CAMRA-1) Trial
Multicentre, double-armed, randomized controlled trial designed to compare mitral valve leaflet resection versus leaflet preservation with regards to the development of functional mitral stenosis following surgical repair of mitral valve prolapse. Patients will be randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed by echocardiographic and clinical assessment at 12-months following surgery.
Mitral valve repair has emerged as the preferred surgical treatment for mitral valve prolapse (MVP), a condition wherein the mitral valve does not close properly. One common strategy for mitral valve repair is leaflet resection, which involves removing part of one or both of the mitral leaflets that flop or bulge back (prolapse). Another strategy is leaflet preservation, which involves placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). While both strategies are routinely used and lead to successful mitral valve repair, there is no clear evidence as to whether one strategy is better than the other in terms of long term outcome. The purpose of this study is to determine if one repair strategy (leaflet resection versus leaflet preservation) leads to better longer term patient outcomes. A total of 88 patients from 6 Canadian centres will be randomly assigned to one of the two strategies. The primary outcome will be functional mitral stenosis (MS) as assessed by 12-month mean mitral valve pressure gradient at peak exercise. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02499419 -
Exercise Capacity Evaluation in Patients With Non-rheumatic Mitral Valve Prolapse (MVP)
|
N/A | |
Completed |
NCT02512341 -
Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics
|
||
Completed |
NCT02105480 -
Automated Algorithm Based Analysis of Phonocardiograms of Newborns
|
||
Enrolling by invitation |
NCT04067635 -
Primary Mitral Regurgitation Repair
|
||
Recruiting |
NCT06378996 -
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
|
N/A | |
Terminated |
NCT03285724 -
Safety and Performance Study of the Harpoon Mitral Valve Repair System
|
N/A | |
Recruiting |
NCT03506217 -
Using Pulse Counter Vigileo-Flotrac System in Transapical Off-pump Minimally Invasive Mitral Valve Repair
|
||
Completed |
NCT00665301 -
Cardiac Output Pulmonary Arterial Catheter Compared to FloWaveâ„¢ 1000
|
N/A | |
Not yet recruiting |
NCT04299334 -
Neochordae Technique in Mitral Valve Repair
|
Phase 1 | |
Completed |
NCT03470155 -
Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function
|
||
Recruiting |
NCT06341166 -
Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse
|
||
Completed |
NCT04231903 -
Myocardial Protection in Minimally Invasive Mitral Valve Surgery
|
||
Not yet recruiting |
NCT03609931 -
Patient Specific Mitral Valve Modeling for Surgical Planning and Training
|
||
Recruiting |
NCT05631730 -
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
|
Phase 3 | |
Recruiting |
NCT01719211 -
Genetic Basis of Mitral Valve Prolapse
|
||
Recruiting |
NCT04190602 -
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
|
||
Recruiting |
NCT03113552 -
Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty
|
||
Recruiting |
NCT06255457 -
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
|
||
Completed |
NCT02771275 -
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
|
N/A | |
Recruiting |
NCT05562804 -
Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery
|