Clinical Trials Logo

Clinical Trial Summary

Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.


Clinical Trial Description

Current ACC/AHA guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. There are those who advocate for performing early "prophylactic" mitral valve surgery while others advocate clinical follow-up until triggers emerge with echocardiography historically being the method used for longitudinal assessment of cardiac anatomy and function. Two studies showed that only ~30% of asymptomatic severe mitral regurgitation made endpoints that triggered. However, these studies were limited and did not perform rigorous follow up assessment of regurgitant volume, left ventricular hemodynamics, exercise capacity, or quality of life assessment. In addition, in these studies mitral regurgitation and left ventricular size and function was assessed by echocardiography. Echocardiography has known limitations in assessing ventricular size and, as recent studies have shown, may not be the optimal modality to assess mitral regurgitant severity. MRI is the gold standard for non-invasive quantification of the left and right ventricles volumes and function and has emerged as a reference standard for quantifying mitral regurgitation. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04051411
Study type Observational
Source Atlantic Health System
Contact SETH URETSKY, MD
Phone 9739715597
Email seth.uretsky@atlantichealth.com
Status Recruiting
Phase
Start date August 7, 2019
Completion date January 2024

See also
  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 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
Completed NCT05850026 - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
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