Recruiting

TEER vs. Surgery

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT07605715

Conditions

Degenerative Mitral Valve Disease

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Study Details

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. 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.

Conditions

Degenerative Mitral Valve Disease

Study ID

NCT07605715

Start date

Feb 19, 2025

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention [ Time Frame: From procedure to 3 years after procedure ]

Central Contacts and Locations

Central contacts

Aakriti Gupta, M.D.

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

Locations

Smidt Heart Institute, Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Aakriti Gupta, M.D.

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

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • TEER
  • Transcatheter mitral repair
  • Surgical mitral repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-05-26.