Percutaneous Repair With the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation - MITRA-FR

Contribution To Literature:

The MITRA-FR trial failed to show that percutaneous mitral valve repair was superior to medical therapy at preventing adverse events.


The goal of the trial was to evaluate percutaneous mitral valve repair (MitraClip) compared with medical therapy among patients with severe functional mitral regurgitation.

Study Design

  • Randomized
  • Parallel

Patients with severe secondary mitral regurgitation were randomized to percutaneous mitral valve repair (n = 152) versus medical therapy (n = 152). The results were the same among all tested subgroups.

  • Total number of enrollees: 304
  • Duration of follow-up: 12 months
  • Mean patient age: 70 years
  • Percentage female: 21%

Inclusion criteria:

  • Symptomatic heart failure
  • Severe secondary mitral regurgitation defined as effective regurgitant orifice >20 mm2 or regurgitant volume >30 cc/beat
  • Left ventricular ejection fraction 15-40%

Exclusion criteria:

  • Candidates for mitral valve surgery

 Other salient features/characteristics:

  • Reduction in mitral regurgitation of at least 2 grades: 92%

Principal Findings:

The primary outcome, death or hospitalization for heart failure, occurred in 54.6% of the percutaneous mitral valve repair group compared with 51.3% of the medical therapy group (p = 0.53).

Secondary outcomes:

  • Death: 24.3% of the percutaneous mitral valve repair group versus 22.4% of the medical therapy group (p = not significant)
  • Hospitalization for heart failure: 48.7% of the percutaneous mitral valve repair group versus 47.4% of the medical therapy group (p = not significant)


Among patients with severe secondary mitral regurgitation, percutaneous mitral regurgitation repair (MitraClip) was not beneficial. The MitraClip device was not associated with a reduction in the composite (or individual components) of death or hospitalization for heart failure. The MitraClip device was effective since 92% of patients experienced a reduction in mitral regurgitation of at least 2 grades; however, follow-up echocardiographic data was incompletely reported. The lack of benefit was likely due to the poor prognosis of the severe underlying cardiomyopathy.   


Obadia JF, Messika-Zeitoun D, Leurent G, et al., on behalf of the MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med 2018;379:2297-2306.

Editorial: Nishimura RA, Bonow RO. Percutaneous Repair of Secondary Mitral Regurgitation — A Tale of Two Trials. N Engl J Med 2018;379:2374-6.

Presented by Dr. Jean-Francois Obadia at the European Society of Cardiology Congress, Munich, Germany, August 27, 2018.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation

Keywords: ESC Congress, ESC18, Cardiac Surgical Procedures, Cardiomyopathies, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency, Primary Prevention, Stroke Volume

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