Degenerative Mitral Valve Disease Clinical Trial
Official title:
A Study to Assess the Effects of Two Commonly Used Mitral Valve Annuloplasty Rings in Mitral Valve Repair on Short-term Outcomes.
Recently published work has suggested that mitral valve annuloplasty ring type may affect the
development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and
poor functional status. However, these results have not been comprehensively determined in a
systematic manner on a general mitral valve repair population. As well, an underlying
mechanism for these findings is not understood.
The investigators hypothesize that mitral valve repair with a complete annuloplasty ring
(Carpentier-Edwards Physio II) when compared to repair with a partial annuloplasty ring
(Simplici- T) may not necessarily result in elevated mitral gradients consistent with
functional mitral stenosis (FMS). Currently no prospective data exists to test the hypothesis
that a correctly sized, flexible complete annuloplasty ring has detrimental effects.
As 60% of annuloplasty rings used in surgical repair of degenerative mitral valve disease in
North America utilizes one of the many forms of complete flexible rings available, this
information is urgently required.
The investigators will evaluate: 1) the effect on mitral valve hemodynamics, 2) changes to
mitral annular, valvular and subvalvular structure and function with 3D echocardiography, and
3) the effect on patient functional capacity at 1 year.
If FMS early post repair is a real phenomenon, the investigators hope to better understand
the mechanisms through the use of advanced imaging techniques-namely 3D modeling of the
mitral valvular apparatus, aortic mitral interactions and LV remodeling.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05774769 -
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
|
||
| Completed |
NCT05839782 -
Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair
|
||
| Completed |
NCT05836532 -
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
|
||
| Recruiting |
NCT03706833 -
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
|
N/A | |
| Recruiting |
NCT05655897 -
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
|
N/A | |
| Enrolling by invitation |
NCT04734756 -
Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation
|
N/A | |
| Enrolling by invitation |
NCT04067635 -
Primary Mitral Regurgitation Repair
|
||
| Active, not recruiting |
NCT06021509 -
Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation
|
N/A | |
| Not yet recruiting |
NCT04679662 -
EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
|
N/A | |
| Active, not recruiting |
NCT04281940 -
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
|
N/A | |
| Not yet recruiting |
NCT05417945 -
A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System
|
N/A | |
| Recruiting |
NCT03433274 -
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
|
N/A | |
| Active, not recruiting |
NCT03674593 -
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
|
N/A | |
| Recruiting |
NCT05595226 -
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
|
N/A | |
| Terminated |
NCT04666480 -
Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
|
N/A |