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Clinical Trials/NCT07605715
NCT07605715RecruitingNot Applicable

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

Cedars-Sinai Medical Center1 site in 1 country60 target enrollmentStarted: February 19, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aakriti Gupta

Assistant Professor, Cardiology

Cedars-Sinai Medical Center

Study Sites (1)

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