Mitral Regurgitation Clinical Trial
Official title:
The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) "Transseptal (TS) Valve-in-MAC" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.
STUDY OBJECTIVE The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) valves with Commander delivery system in patients with severe mitral annular calcification and symptomatic mitral valve dysfunction who are not candidates for standard mitral valve surgery. STUDY DESIGN A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 arms in this study: 1) "Transseptal (TS) Valve-in-MAC (ViMAC)" arm, 2) Natural History of Disease Registry (NHDR). Patients treated with medical treatment only (which will include patients who meet inclusion criteria but can't be treated with transseptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e. alcohol septal ablation, radiofrequency ablation). Enrollment Enrollment will consist of 110 patients in the treatment arm (transseptal ViMAC) and up to 100 in the medically treated arm). ;
| 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 |
NCT06465745 -
AltaValve Pivotal Trial
|
N/A | |
| Not yet recruiting |
NCT06167213 -
ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral
|
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
|
||
| Completed |
NCT01841554 -
Cardioband With Transfemoral Delivery System
|
N/A | |
| Not yet recruiting |
NCT01431222 -
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
|
Phase 4 | |
| 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 |
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
|
||
| Completed |
NCT05836532 -
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
|
||
| 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 |