Mitral Valve Disease
Conditions
Keywords
Mitral regurgitation, Mitral stenosis, Mitral valve repair deterioration, Bioprosthesis degeneration
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.
Interventions
None listed
Sponsors
French Cardiology Society
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
CONTACTJean-François OBADIA
CONTACTBernard IUNG
PRINCIPAL_INVESTIGATORJean-François OBADIA
Hospices Civils de Lyon
PRINCIPAL_INVESTIGATORBernard IUNG
Assistance Publique - Hôpitaux de Paris
PRINCIPAL_INVESTIGATORPatrice GUERIN
Nantes University Hospital
Outcome results
None listed