Mitral Regurgitation Clinical Trial
Official title:
The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise Capacity
NCT number | NCT04051411 |
Other study ID # | 1444724 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 7, 2019 |
Est. completion date | January 2024 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age >=18 yrs 2. able to give informed consent 3. Diagnoses of moderate or severe degenerative mitral regurgitation (based on the integrated approach recommended by the American Society of Echocardiography) Exclusion Criteria: 1. Left ventricular ejection fraction <60% 2. Heart failure 3. Pulmonary hypertension (pulmonary artery systolic pressure >40mmHg at rest or >60mmHg with exercise as assessed by echocardiography) 4. Atrial fibrillation 5. Concomitant > mild aortic or mitral stenosis, >mild aortic or tricuspid or pulmonic regurgitation 6. Prior valvular heart disease surgery 7. Hypertrophic cardiomyopathy or an infiltrative cardiomyopathy 8. Unable to exercise on a treadmill 9. Symptomatic coronary artery disease 10. Comorbidities expected to impact functional capacity and confound symptom assessment (e.g COPD) 11. Expected lifespan of less than 2 years |
Country | Name | City | State |
---|---|---|---|
United States | Morristown Medical Center | Morristown | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Atlantic Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mitral regurgitant volume | Change in mitral regurgitant volume quantified by MRI over follow-up period | Entry into study, 1 year, and 2 years | |
Secondary | Change in left ventricular end-diastolic volume | Change in left ventricular end-diastolic volume quantified by MRI over follow-up period | Entry into study, 1 year, and 2 years | |
Secondary | Change in symptoms and quality | Change in symptoms and quality of life as measured by EQ5DL questionnaires | Entry into study, 1 year, and 2 years | |
Secondary | Change in exercise capacity | Change in exercise capacity measured by treadmill exercise test | Entry into study, 1 year, and 2 years | |
Secondary | Follow up events | Follow up events defined as death, need for surgery, heart failure symptoms, or valvular disease related hospitalizations | 1 yea, and 2 years | |
Secondary | Change in degree of myocardial fibrosis | Change in degree of myocardial fibrosis measured as the percentage left ventricular hyperenhancement and change in mean ECV | Entry into study, 1 year, and 2 years |
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
|
||
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 |