NCT02925819 Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
| NCT ID | NCT02925819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | French Cardiology Society |
| Condition | Mitral Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2016-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2016-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jean-François OBADIA
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT02925819 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02925819 currently recruiting?
Yes, NCT02925819 is actively recruiting participants. Contact the research team at secretariat.registre@sfcardio.fr for enrollment information.
Where is the NCT02925819 trial being conducted?
This trial is being conducted at Lyon, France, Nantes, France, Paris, France.
Who is sponsoring the NCT02925819 clinical trial?
NCT02925819 is sponsored by French Cardiology Society. The principal investigator is Jean-François OBADIA at Hospices Civils de Lyon. The trial plans to enroll 500 participants.