Registry for patients with severe mitral valve disease not suitable for surgery
Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study
French Cardiology Society · NCT02925819
This study is creating a registry to track the health and treatment of French patients with severe mitral valve disease who can't have surgery, to see how they do over the next two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Cardiology Society (other) |
| Locations | 3 sites (Lyon and 2 other locations) |
| Trial ID | NCT02925819 on ClinicalTrials.gov |
What this trial studies
This study aims to create a prospective registry of French patients with severe mitral valve disease who are not candidates for surgical intervention. Patients will undergo a thorough medical evaluation, including echocardiography, and their demographic, clinical, and treatment data will be collected. The registry will track morbidity and mortality outcomes over a period of 24 months, analyzing various factors that may influence these outcomes. This observational approach allows for a comprehensive understanding of the clinical management of this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with symptomatic severe mitral valve stenosis or regurgitation who are deemed ineligible for surgical treatment.
Not a fit: Patients who are asymptomatic or those who are eligible for surgical treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management and outcomes of patients with severe mitral valve disease who cannot undergo surgery.
How similar studies have performed: While similar observational studies have been conducted, this specific registry approach for patients not suitable for surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lyon and 2 other locations
- CHU Lyon — Lyon, France (RECRUITING)
- CHU Nantes — Nantes, France (RECRUITING)
- Bichat Hospital — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Jean-François OBADIA — Hospices Civils de Lyon
- Study coordinator: Jean-François OBADIA
- Email: secretariat.registre@sfcardio.fr
- Phone: +331 43 22 33 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mitral Valve Disease, Mitral regurgitation, Mitral stenosis, Mitral valve repair deterioration, Bioprosthesis degeneration