Registry of Aortic Valve Bioprostheses Established by Catheter (FRANCE-TAVI)
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|ClinicalTrials.gov Identifier: NCT01777828|
Recruitment Status : Recruiting
First Posted : January 29, 2013
Last Update Posted : August 27, 2020
|Condition or disease|
|Transcatheter Aortic Valve 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
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Registry of Aortic Valve Bioprostheses Established by Catheter|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2033|
|Estimated Study Completion Date :||February 2034|
Transcatheter Aortic Valve Implantation
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 .
- 1-year survival [ Time Frame: 1 year ]After leaving the hospital, the doctor responsible for the register in each center will contact the patient or his family and referring physicians by phone to take new or fix an appointment for consultation. The study is purely observational, it does not require special monitoring visits but involves collecting data obtained during routine follow-up visits.
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): NCT01777828
|Contact: Hervé Lebreton||33(1) 44 90 70 firstname.lastname@example.org|
|Contact: Nicole NACCACHE||33(1) 44 90 70 email@example.com|
|CHU Rennes - Pontchaillou||Recruiting|
|Rennes, France, 35000|
|Contact: Hervé Le Breton firstname.lastname@example.org|
|Principal Investigator: Hervé Le Breton|
|Principal Investigator:||Hervé Le Breton||AP|