An observational study in Transcatheter Aortic Valve Implantation, sponsored by French Cardiology Society. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by French Cardiology Society · Observational
The aim of this registry is to evaluate the overall survival up to 10 years of patients with aortic valve bioprostheses implanted via the transarterial or transapical route. Data from the register is enhanced by matching it with continuous data in the SNDS.
Mandated by the French health authorities, this registry must be maintained as part of the management of any patient undergoing transarterial or transapical aortic valve bioprosthesis implantation.
Participation in the registry is offered to all subjects eligible for bioprosthesis implantation.
Aortic valve stenosis is a serious chronic life-threatening in the short or medium term since the onset of functional symptoms. Aortic valve replacement surgery is currently the treatment of choice. It is done by surgery with sternotomy and extracorporeal circulation. However, despite the considerable improvement of the conditions of care per and post operative, this procedure is sometimes burdened with high mortality, especially in the population with severe co-morbidities and / or many. For this reason, some patients are considered against the indicated surgery or high surgical risk.
The recent development of aortic valve bioprostheses implanted with new approaches (pressure or transapical) can be considered for aortic valve replacement in a population that was previously excluded.
Based on very thorough evaluation of these valves test benches and animal as well as human settlements achieved through multiple studies and registries mono or multi patients challenged by cardiac surgeons or considered at high surgical risk, it is clear that the implementation of these valves could allow, under conditions of optimal implementation and monitoring, improve short-and long-term clinical status, quality of life and prognosis of patients.
FRANCE 2 registry, established in 2010, and whose inclusions ended 30 June 2012 has allowed an initial assessment of aortic valve bioprostheses implanted catheter The following registry France 2 has been requested by the highest authorities of health, FRANCE register TAVI is performed in continuity FRANCE 2. It takes account of the first data FRANCE 2. Data Report Form has been reduced, no new item has been added, it will be carried out in all centers authorized in France to implement this technique. The collection of data will TAVI France under the same conditions as those FRANCE 2, the database will be managed by the French Society of Cardiology
French Cardiology Society is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participation in the registry will be offered to all subjects eligible for bioprosthesis implantation.
Inclusion Criteria: Patients who have undergone transarterial or transapical aortic valve bioprosthesis implantation
Exclusion Criteria: Patient has not given consent
FRANCE TAVI registry aims to identify all patients with a change of valves implanted catheter meets the selection criteria of the technical accepting the scheduled evaluations in the context of this disease and who have agreed to participate in the study .
10 year survival
After leaving the hospital, the doctor responsible for the register in each center will contact annually the patient or his family and referring physicians by phone to take new or fix an appointment for consultation. This data is supplemented by automatic collection through the SNDS link. The study is purely observational, it does not require special monitoring visits but involves collecting data obtained during routine follow-up visits.
Time frame: 10 year
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
French Cardiology Society