Registry for 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
Run by French Cardiology Society · NCT02925819 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | French Cardiology Society Academic / other |
| Locations | 3 sites (Lyon and 2 other locations) |
| Status | Recruiting |
| Started | October 2016 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT02925819 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years with symptomatic severe mitral valve stenosis or regurgitation who are deemed ineligible for surgical treatment.
✕Probably not a fit
Patients who are asymptomatic or those who are eligible for surgical treatment will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar observational studies have been conducted, this specific registry approach for patients not suitable for surgery is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
MRace Implant: A first look at fixing the mitral valve to reduce regurgitation
This single-arm study tests whether the MRace Implant and Delivery System can safely place a prosthesis to reduce severe mitral regurgitation in high-risk patients who may not be good candidates for open-heart surgery.
-
Mitral Valve Calcification Imaging with TrueVue 3D Light Rendering
This study tests how well three-dimensional transesophageal echocardiography with TrueVue transillumination detects mitral valve calcifications compared with CT in adults.
-
Tracking progression and consequences of heart valve disease
This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.
-
Surgical implantation of a polymer prosthetic mitral or aortic valve
This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.
-
Abbott Cephea registry for mitral valve disease
Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.
-
Using the CoolCryo System to treat Atrial Fibrillation during Mitral Valve Surgery
This study is testing whether the CoolCryo system can safely help people with atrial fibrillation feel better during mitral valve surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.