Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation

Conditions

• Degenerative Mitral Valve Disease

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Feb 19, 2025

Status verified

May 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

60 participants (estimated)

Arms

• Arm: 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.
• Arm: 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

• Aakriti Gupta, M.D.
  267-442-8776
  [email protected]

Locations (1)

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