Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery (MITRAGISTER)
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|ClinicalTrials.gov Identifier: NCT02925819|
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : August 14, 2019
|Condition or disease|
|Mitral Valve Disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2022|
SEVERE MITRAL VALVE DISEASE
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.
- All cause death and heart failure at 24 months [ Time Frame: 24 months of follow-up ]Death from any cause or unscheduled hospitalization for heart failure at 24 months
- Overall survival at 24 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 months of follow-up ]Rate of unscheduled hospitalizations for heart failure at 24 months.
- Functional evaluation [ Time Frame: 24 months of follow-up ]It will be defined by changes in NYHA functional class at 24 months.
- Early safety [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925819
|Contact: Jean-François OBADIA||+331 43 22 33 email@example.com|
|Contact: Bernard IUNG||+331 43 22 33 firstname.lastname@example.org|
|Contact: Jean-Francois Obadia|
|Contact: Patrice Guérin|
|Contact: Bernard Iung|
|Principal Investigator:||Jean-François OBADIA||CHU Lyon|
|Principal Investigator:||Bernard IUNG||Assistance Publique - Hôpitaux de Paris|
|Principal Investigator:||Patrice GUERIN||CHU Nantes|