Management and Clinical Outcomes of Patients With Severe Mitral Disease Not Suitable for Surgery: A Prospective Multicenter Observational Study

What this Trial Is About

This research aims to collect information on French patients with symptomatic severe mitral valve disease who cannot undergo surgery due to high risk or contraindications. It focuses on those with disease on a native valve or worsening after previous valve repair or replacement. The study will evaluate the risks of illness and death over 24 months for patients not included in other clinical trials, analyzing how various patient characteristics and treatments relate to these outcomes. Patients undergo medical evaluations including physical exams, ECGs, blood tests, and echocardiography. Data on demographics, clinical status, lab results, and treatments are gathered in an electronic form at each participating center. Patient monitoring includes phone calls at 6 months and medical visits with echocardiography at 1 and 2 years to track their condition and treatment effects. Participants will be followed for two years to assess outcomes like all-cause death, heart failure, survival rates, hospitalizations, functional status, and early safety up to hospital discharge. The study collects detailed clinical and imaging data to understand the progression of severe mitral valve disease in patients unsuitable for surgery and how different factors influence their health over time.

Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery