Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
- Conditions
- Mitral Valve Disease
- Registration Number
- NCT02925819
- Lead Sponsor
- French Cardiology Society
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All cause death and heart failure at 24 months 24 months of follow-up Death from any cause or unscheduled hospitalization for heart failure at 24 months
- Secondary Outcome Measures
Name Time Method Overall survival at 24 months 24 months of follow-up The survival rate will be determined between the date of inclusion in the cohort and the date of occurrence of death, whatever the cause.
Survival without major cardiovascular event 24 months of follow-up The rate of survival without major cardiovascular event rate will be determined between the date of inclusion and date of occurrence of a major cardiovascular event (unscheduled rehospitalisation for heart failure, stroke, death of cardiovascular, myocardial infarction).
Rate of unscheduled hospitalizations for heart failure 24 months of follow-up Rate of unscheduled hospitalizations for heart failure at 24 months.
Functional evaluation 24 months of follow-up It will be defined by changes in NYHA functional class at 24 months.
Early safety Until Hospital Discharge, up to 6 months Defined as absence of all-cause mortality, all stroke, severe bleeding, acute kidney injury stage 2 or 3, major vascular complication, and valve related dysfunction requiring repeat interventional transcatheter procedure or surgery.
Trial Locations
- Locations (3)
CHU Nantes
🇫🇷Nantes, France
CHU Lyon
🇫🇷Lyon, France
Bichat Hospital
🇫🇷Paris, France