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NCT Number: NCT07605715

Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation

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.

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Key information

Conditions

Degenerative Mitral Valve Disease

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Smidt Heart Institute, Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Aakriti Gupta, M.D.

CONTACT

[email protected]

267-442-8776

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention

    Time frame: From procedure to 3 years after procedure

    Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention

Secondary outcomes

  1. 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

    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.

  2. Left Ventricular Ejection Fraction by Transthoracic Echocardiography

    Time frame: 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.

  3. Mean Mitral Valve Gradient by Transthoracic Echocardiography

    Time frame: 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.

  4. 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

    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.

  5. Six-Minute Walk Test Distance

    Time frame: 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.

  6. 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

    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.

  7. 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

    The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status. Higher scores indicate better mental health status.

  8. 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 all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.

  9. Percentage of Participants With Heart Failure Hospitalization

    Time frame: 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.

  10. Mitral Valve Reintervention

    Time frame: 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.

Other outcomes

  1. Percentage of Participants With One or More Major Periprocedural or 30-Day Complications

    Time frame: From start of procedure to 30 days after procedure

    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.

  2. Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular Ejection Fraction

    Time frame: From baseline CMR to 6 months after procedure

    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.

  3. Difference in 6-Month Left Ventricular Ejection Fraction by Baseline Late Gadolinium Enhancement Presence

    Time frame: From baseline CMR to 6 months after procedure

    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.

  4. Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular End-Systolic Volume Index

    Time frame: From baseline CMR to 6 months after procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aakriti Gupta, M.D.

CONTACT

[email protected]

267-442-8776

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: DMR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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