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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFrench Cardiology Society

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: SEVERE MITRAL VALVE DISEASE

Trial outcomes

Primary outcomes

1

All cause death and heart failure at 24 months

Death from any cause or unscheduled hospitalization for heart failure at 24 months

Time frame
24 months of follow-up

Secondary outcomes

1

Overall survival at 24 months

The survival rate will be determined between the date of inclusion in the cohort and the date of occurrence of death, whatever the cause.

Time frame
24 months of follow-up
2

Survival without major cardiovascular event

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).

Time frame
24 months of follow-up
3

Rate of unscheduled hospitalizations for heart failure

Rate of unscheduled hospitalizations for heart failure at 24 months.

Time frame
24 months of follow-up
4

Functional evaluation

It will be defined by changes in NYHA functional class at 24 months.

Time frame
24 months of follow-up

Other outcomes

Sponsors and contacts

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