Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation

NCT07605715 | Recruiting DMC

• 2 other identifiers: STUDY000035841R56HL175516-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.
2. 2.Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI
3. 3.Assess patient-reported recovery and quality of life outcomes using validated tools.

Conditions

Degenerative Mitral Valve Disease

Keywords

TEER; Transcatheter mitral repair; Surgical mitral repair

Outcome Measures

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

  From procedure to 3 years after procedure

Secondary Outcomes (10)

• Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography

  At 30 days, 6 months, and 1 year after procedure

• Left Ventricular Ejection Fraction by Transthoracic Echocardiography

  At 30 days, 6 months, and 1 year after procedure

• Mean Mitral Valve Gradient by Transthoracic Echocardiography

  At 30 days, 6 months, and 1 year after procedure

• Kansas City Cardiomyopathy Questionnaire Overall Summary Score

  At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure

• Six-Minute Walk Test Distance

  At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure

Other Outcomes (4)

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

  From start of procedure to 30 days after procedure

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

  From baseline CMR to 6 months after procedure

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

  From baseline CMR to 6 months after procedure

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients older than 60 years who have DMR will be included in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Smidt Heart Institute, Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Central Study Contacts

Aakriti Gupta, M.D.

CONTACT

267-442-8776; aakriti.gupta@cshs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Cardiology

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: May 26, 2026
• Study Start: February 19, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

US (1)