Registry of Aortic Valve Bioprostheses Established by Catheter

NCT01777828 | Recruiting

• 1 other identifier: 12650
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transcatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (1)

• 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.

  10 year

Study Arms (1)

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 .

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participation in the registry will be offered to all subjects eligible for bioprosthesis implantation.

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (1)

CHU Rennes - Pontchaillou

Rennes, 35000, France

RECRUITING

Related Publications (8)

• Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.

  PMID: 22551129 BACKGROUND

• Auffret V, Lefevre T, Van Belle E, Eltchaninoff H, Iung B, Koning R, Motreff P, Leprince P, Verhoye JP, Manigold T, Souteyrand G, Boulmier D, Joly P, Pinaud F, Himbert D, Collet JP, Rioufol G, Ghostine S, Bar O, Dibie A, Champagnac D, Leroux L, Collet F, Teiger E, Darremont O, Folliguet T, Leclercq F, Lhermusier T, Olhmann P, Huret B, Lorgis L, Drogoul L, Bertrand B, Spaulding C, Quilliet L, Cuisset T, Delomez M, Beygui F, Claudel JP, Hepp A, Jegou A, Gommeaux A, Mirode A, Christiaens L, Christophe C, Cassat C, Metz D, Mangin L, Isaaz K, Jacquemin L, Guyon P, Pouillot C, Makowski S, Bataille V, Rodes-Cabau J, Gilard M, Le Breton H; FRANCE TAVI Investigators. Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI. J Am Coll Cardiol. 2017 Jul 4;70(1):42-55. doi: 10.1016/j.jacc.2017.04.053.

  PMID: 28662806 RESULT

• Auffret V, Bedossa M, Boulmier D, Verhoye JP, Ruggieri VG, Koning R, Laskar M, Van Belle E, Leprince P, Collet JP, Iung B, Lefevre T, Eltchaninoff H, Gilard M, Le Breton H. [From FRANCE 2 to FRANCE TAVI: are indications, technique and results of transcatheter aortic valve replacement the same?]. Presse Med. 2015 Jul-Aug;44(7-8):752-60. doi: 10.1016/j.lpm.2015.05.004. Epub 2015 Jul 22. French.

  PMID: 26208911 RESULT

• Folliguet TA, Teiger E, Beurtheret S, Modine T, Lefevre T, Van Belle E, Gilard M, Eltchaninoff H, Koning R, Iung B, Verhoye JP, Leprince P, Le Breton H, Lafont A, Parolari A, Barili F. Carotid versus femoral access for transcatheter aortic valve implantation: a propensity score inverse probability weighting study. Eur J Cardiothorac Surg. 2019 Dec 1;56(6):1140-1146. doi: 10.1093/ejcts/ezz216.

  PMID: 31365061 RESULT

• Benamer H, Auffret V, Cayla G, Chevalier B, Dupouy P, Eltchaninoff H, Gilard M, Guerin P, Iung B, Koning R, Monsegu J, Lantelme P, Le Breton H, Lefevre T, Verhoye JP, Commeau P, Motreff P. Position paper of French Interventional Group (GACI) for TAVI in France in 2018. Ann Cardiol Angeiol (Paris). 2018 Dec;67(6):455-465. doi: 10.1016/j.ancard.2018.09.021. Epub 2018 Oct 28.

  PMID: 30376969 RESULT

• Deharo P, Jaussaud N, Grisoli D, Camus O, Resseguier N, Le Breton H, Auffret V, Verhoye JP, Koning R, Lefevre T, Van Belle E, Eltchaninoff H, Gilard M, Leprince P, Iung B, Lambert M, Collart F, Cuisset T. Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes: Insights From the FRANCE TAVI Registry. JACC Cardiovasc Interv. 2018 Oct 8;11(19):1956-1965. doi: 10.1016/j.jcin.2018.06.023. Epub 2018 Sep 12.

  PMID: 30219324 RESULT

• Didier R, Gouysse M, Eltchaninoff H, Le Breton H, Commeau P, Cayla G, Glatt N, Glatt B, Gabbas M, Tuppin P, Liepchitz L, Boussac M, Iung B, Gilard M. Successful linkage of French large-scale national registry populations to national reimbursement data: Improved data completeness and minimized loss to follow-up. Arch Cardiovasc Dis. 2020 Aug-Sep;113(8-9):534-541. doi: 10.1016/j.acvd.2020.04.006. Epub 2020 Jul 22.

  PMID: 32712203 RESULT

• Van Belle E, Vincent F, Labreuche J, Auffret V, Debry N, Lefevre T, Eltchaninoff H, Manigold T, Gilard M, Verhoye JP, Himbert D, Koning R, Collet JP, Leprince P, Teiger E, Duhamel A, Cosenza A, Schurtz G, Porouchani S, Lattuca B, Robin E, Coisne A, Modine T, Richardson M, Joly P, Rioufol G, Ghostine S, Bar O, Amabile N, Champagnac D, Ohlmann P, Meneveau N, Lhermusier T, Leroux L, Leclercq F, Gandet T, Pinaud F, Cuisset T, Motreff P, Souteyrand G, Iung B, Folliguet T, Commeau P, Cayla G, Bayet G, Darremont O, Spaulding C, Le Breton H, Delhaye C. Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry. Circulation. 2020 Jan 28;141(4):243-259. doi: 10.1161/CIRCULATIONAHA.119.043785. Epub 2019 Nov 16.

  PMID: 31736356 DERIVED

Central Study Contacts

Martine GILARD

CONTACT

33(1) 44 90 70 28; francetavi@sfcardio.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: February 1, 2013
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2034
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

FR (1)