Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation
ConditionDegenerative Mitral Valve Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 60 years who have DMR will be included in the study
Disqualifiers
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.
Trial population
The study population includes adult patients with severe degenerative mitral regurgitation (DMR) who underwent either surgical mitral valve repair or transcatheter edge-to-edge repair (TEER).
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Surgical mitral repair
Group B: Transcatheter mitral edge-to-edge repair
Trial outcomes
Primary outcomes
1
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Time frame
From procedure to 3 years after procedureSecondary outcomes
1
Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
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.
Time frame
At 30 days, 6 months, and 1 year after procedure2
Left Ventricular Ejection Fraction by Transthoracic Echocardiography
Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
Time frame
At 30 days, 6 months, and 1 year after procedure3
Mean Mitral Valve Gradient by Transthoracic Echocardiography
Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
Time frame
At 30 days, 6 months, and 1 year after procedure4
Kansas City Cardiomyopathy Questionnaire Overall Summary Score
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.
Time frame
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedureOther outcomes
1
Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Percentage of participants with one or more major periprocedural or 30-day complications after surgical mitral valve repair or transcatheter edge-to-edge repair. Major complications include coronary obstruction, cardiac tamponade, new left bundle branch block, major bleeding, stroke or transient ischemic attack, myocardial infarction, acute kidney injury, new-onset atrial fibrillation, infection or sepsis, permanent pacemaker implantation, or conversion to open surgery.
Time frame
From start of procedure to 30 days after procedure2
Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular Ejection Fraction
Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular ejection fraction, measured as percentage by transthoracic echocardiography at 6 months after procedure.
Time frame
From baseline CMR to 6 months after procedure3
Difference in 6-Month Left Ventricular Ejection Fraction by Baseline Late Gadolinium Enhancement Presence
Difference in 6-month left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, between participants with and without baseline late gadolinium enhancement on cardiovascular magnetic resonance imaging.
Time frame
From baseline CMR to 6 months after procedure4
Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular End-Systolic Volume Index
Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular end-systolic volume index, measured in mL/m² by cardiovascular magnetic resonance imaging at 6 months after procedure.
Time frame
From baseline CMR to 6 months after procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cedars-Sinai Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov