Mitral Regurgitation Clinical Trial
Official title:
Prospective.Randomized, Blinded, Crossover Chronic IDE Study of the Effects of Pacing on Mitral Regurgitation in Patients Without Standard Indications for Cardiac Resynchronization Therapy
The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO per American Society of ECHO guidelines) and to show that CRT pacing is safe in these patients.
Approximately 50 patients will be randomized, followed and analyzed in this prospective study. Patients who meet all inclusion and no exclusion criteria will be enrolled and implanted with a CRT system. Baseline evaluation, which includes clinical symptom evaluation and an echocardiogram, will be performed at the time of randomization, which should occur as soon after device implant as possible but no later than 2 week post -implant. The baseline echocardiogram should be acquired prior to the device being programmed to the randomized setting. Repeat echocardiograms and scheduled follow-up evaluations will be performed at the end of each 3 month crossover period. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Withdrawn |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Withdrawn |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 |