Degenerative Mitral Valve Disease
Conditions
Keywords
TEER, Transcatheter mitral repair, Surgical mitral repair
Brief summary
The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to: 1. Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term. 2. Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI 3. Assess patient-reported recovery and quality of life outcomes using validated tools. The study focuses on improving care strategies for patients with DMR, particularly those at higher surgical risk, by identifying optimal treatment approaches and predictors of recovery.
Detailed description
This is an ambispective, (prospective and retrospective) cohort study collecting clinical, procedural, and follow-up data to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term.
Interventions
None listed
Sponsors
Cedars-Sinai Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 60 years who have DMR will be included in the study
Exclusion criteria
* Patients with prior history of mitral intervention or surgery will be excluded. * Patient records flagged "break the glass" or "research opt out" will be excluded. * Persons with allergy to animal dander or animal-instigated asthma will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention | From procedure to 3 years after procedure | Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography | At 30 days, 6 months, and 1 year after procedure | Percentage of participants with residual mitral regurgitation greater than 2+ assessed by transthoracic echocardiography after surgical mitral valve repair or transcatheter edge-to-edge repair. |
| Left Ventricular Ejection Fraction by Transthoracic Echocardiography | At 30 days, 6 months, and 1 year after procedure | Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair. |
| Mean Mitral Valve Gradient by Transthoracic Echocardiography | At 30 days, 6 months, and 1 year after procedure | Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair. |
| Kansas City Cardiomyopathy Questionnaire Overall Summary Score | At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure | Kansas City Cardiomyopathy Questionnaire overall summary score, measured on a 0 to 100 scale, will be used to assess patient-reported health status after surgical mitral valve repair or transcatheter edge-to-edge repair. Higher scores indicate better health status. |
| Six-Minute Walk Test Distance | At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure | Functional capacity will be assessed using the 6-minute walk test distance, measured in meters. |
| SF-36 Physical Component Summary Score | At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure | The SF-36 Physical Component Summary score will be used to assess patient-reported physical health status. Scores are reported as scale scores, with higher scores indicating better physical health status. |
| SF-36 Mental Component Summary Score | At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure | The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status. Higher scores indicate better mental health status. |
| Percentage of Participants With All-Cause Mortality | At 30 days, 6 months, 1 year, and 5 years after procedure | Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair. |
| Percentage of Participants With Heart Failure Hospitalization | At 30 days, 6 months, 1 year, and 5 years after procedure | Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair. |
| Mitral Valve Reintervention | At 30 days, 6 months, 1 year, and 5 years after procedure | Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair. |
Countries
United States
Contacts
CONTACTAakriti Gupta, M.D.
Outcome results
None listed