Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Degenerative Mitral Valve Disease. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation: A Comparative Study of Clinical Outcomes, Patient Experiences, and Mechanistic Insights With Multimodality Imaging
Overview
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.
Primary outcome measures
- Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention [Time frame: From procedure to 3 years after procedure]
Secondary outcome measures (10)
- Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography [Time frame: At 30 days, 6 months, and 1 year after procedure]
- Left Ventricular Ejection Fraction by Transthoracic Echocardiography [Time frame: At 30 days, 6 months, and 1 year after procedure]
- Mean Mitral Valve Gradient by Transthoracic Echocardiography [Time frame: At 30 days, 6 months, and 1 year after procedure]
- Kansas City Cardiomyopathy Questionnaire Overall Summary Score [Time frame: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure]
- Six-Minute Walk Test Distance [Time frame: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure]
- SF-36 Physical Component Summary Score [Time frame: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure]
- SF-36 Mental Component Summary Score [Time frame: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure]
- Percentage of Participants With All-Cause Mortality [Time frame: At 30 days, 6 months, 1 year, and 5 years after procedure]
- Percentage of Participants With Heart Failure Hospitalization [Time frame: At 30 days, 6 months, 1 year, and 5 years after procedure]
- Mitral Valve Reintervention [Time frame: At 30 days, 6 months, 1 year, and 5 years after procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Smidt Heart Institute, Cedars Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT07605715 · STUDY00003584 · 1R56HL175516-01