Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)

Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation: A Comparative Study of Clinical Outcomes, Patient Experiences, and Mechanistic Insights With Multimodality Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Mitral Valve Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Aakriti Gupta, M.D.; Phone Number: 267-442-8776; Email: aakriti.gupta@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Smidt Heart Institute, Cedars Sinai Medical Center
      • Contact: Aakriti Gupta, M.D.; Phone Number: 267-442-8776; Email: aakriti.gupta@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Surgical mitral repair; This cohort includes patients who underwent surgical mitral valve repair for severe degenerative mitral regurgitation (DMR). The intervention involves standard surgical techniques to repair the mitral valve, aiming to restore its physiological function and reduce mitral regurgitation.
Transcatheter mitral edge-to-edge repair; This cohort includes patients who underwent transcatheter edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR). The intervention involves a minimally invasive transcatheter procedure using a device to approximate the mitral valve leaflets, reducing regurgitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention	Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention	From procedure to 3 years after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 30 days, 6 months, and 1 year after procedure
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.	At 30 days, 6 months, and 1 year after procedure
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.	At 30 days, 6 months, and 1 year after procedure
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.	At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Six-Minute Walk Test Distance	Functional capacity will be assessed using the 6-minute walk test distance, measured in meters.	At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
SF-36 Physical Component Summary Score	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.	At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
SF-36 Mental Component Summary Score	The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status. Higher scores indicate better mental health status.	At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of Participants With All-Cause Mortality	Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.	At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of Participants With Heart Failure Hospitalization	Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair.	At 30 days, 6 months, 1 year, and 5 years after procedure
Mitral Valve Reintervention	Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair.	At 30 days, 6 months, 1 year, and 5 years after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From start of procedure to 30 days after procedure
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.	From baseline CMR to 6 months after procedure
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.	From baseline CMR to 6 months after procedure
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.	From baseline CMR to 6 months after procedure

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: TEER; Transcatheter mitral repair; Surgical mitral repair
• Other Study ID Numbers: STUDY00003584; 1R56HL175516-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No