Clinical trial NCT02925819: Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
Official title: Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Disease
Keywords: Mitral regurgitation
Mitral stenosis
Mitral valve repair deterioration
Bioprosthesis degeneration
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French patients undergoing an assessment for percutaneous treatment of symptomatic severe mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement with contra-indication to or prohibitive risk of surgery.

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.

Eligibility 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

Primary outcomes:
measure: All cause death and heart failure at 24 months
timeFrame: 24 months of follow-up
Secondary outcomes:
measure: Overall survival at 24 months
timeFrame: 24 months of follow-up
measure: Survival without major cardiovascular event
timeFrame: 24 months of follow-up
measure: Rate of unscheduled hospitalizations for heart failure
timeFrame: 24 months of follow-up
measure: Functional evaluation
timeFrame: 24 months of follow-up
measure: Early safety
timeFrame: Until Hospital Discharge, up to 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: CHU Lyon
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-François OBADIA
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bernard IUNG
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Patrice GUERIN
role: PRINCIPAL_INVESTIGATOR
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