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

French Cardiology Society

Status: Enrolling

Conditions: Mitral Valve Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02925819

15.534

Details and patient eligibility

About

The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.

Full description

Patients with symptomatic severe mitral valve disease will have a medical evaluation visit (physical examination, ECG, biology) with transthoracic ± transesophageal echocardiography in each center. If the patient is considered not eligible for surgery by the heart-team and is not included in a clinical trial, the investigator informs the patient of the existence of the registry and verifies that it does not express opposition to the use of its clinical data.

In each participating center, demographic information, clinical, laboratory, echocardiographic and treatment options will be collected and reported in an electronic case report form (e-CRF). Each center will be responsible of patient monitoring, including phone call at 6 months and a medical visit at 1 and 2 years. Transthoracic echocardiography will also be performed at 1 year and 2 years.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Aged over 18 years
• Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification)
• Symptomatic (NYHA functional class II-IV) despite optimized medical therapy
• Judged not eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
• Having received information about the study and not expressing opposition to the use of their data
• Patient not included in a clinical trial

Exclusion Criteria:

• Asymptomatic patients
• Absence of severe mitral regurgitation or stenosis
• Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
• Pregnant or breastfeeding women
• Having not received information about the study or having expressed opposition to the use of their data

Trial design

500 participants in 1 patient group

SEVERE MITRAL VALVE DISEASE

Description:

All patients with symptomatic severe mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement, and not eligible for surgery according to the heart-team.