Effective Management of Calcific Aortic Stenosis in the Elderly

NCT03343314 | Completed

• 1 other identifier: 15945
• Study Type: observational
• Target: 1,101
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities. Transcatheter Aortic Valve Implantation (TAVI) has recently extended the therapeutic indications in patients at high risk of surgery. However, the proportion of different treatments is not known in a contemporary population that can be treated according to the different resources currently available. The scientific goal of this observational research is to evaluate intra-hospital therapeutic decision in elderly patients referred because of symptomatic severe aortic stenosis. The one-year survival will be analyzed according to the therapeutic decision and the characteristics of the patients.

Conditions

Calcific Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Collate the therapeutic decision (medical treatment, TAVI [Transcatheter Aortic Valve Implantation] or surgical aortic valve replacement) comprehensively for all hospitalized patients because of a severe, symptomatic RAC.

  The primary endpoint is the therapeutic indication retained by the medical-surgical team in charge of the patient during hospitalization: medical treatment, TAVI or surgical aortic valve replacement.

  1 day

Secondary Outcomes (1)

• 1 year-survival

  1 year

Study Arms (1)

Hospitalized patients due to a severe, symptomatic aortic sten

Patients who agreed to participate in the study, aged ≥75 years, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical and surgical centers participating in the study

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multicenter study to prospectively include all patients who agreed to participate in the study, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical-surgical centers participating in the study and offering all the therapeutic resources for the taking into account charge of patients with aortic stenosis

You may qualify if:

• Hospitalized due to symptomatic tight aortic stenosis (NYHA \>= II, dyspnea, angina or syncope);
• Having given his consent to participate in the study.

You may not qualify if:

• Non-severe aortic stenosis;
• Asymptomatic aortic stenosis;
• Patient under the age of 75;
• Patient refusing to participate in the study.

Sponsors & Collaborators

• French Cardiology Society: lead

Related Publications (15)

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  PMID: 20403489 BACKGROUND

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• Martinez-Selles M, Gomez Doblas JJ, Carro Hevia A, Garcia de la Villa B, Ferreira-Gonzalez I, Alonso Tello A, Andion Ogando R, Ripoll Vera T, Arribas Jimenez A, Carrillo P, Rodriguez Pascual C, Casares i Romeva M, Borras X, Cornide L, Lopez-Palop R; PEGASO Registry Group. Prospective registry of symptomatic severe aortic stenosis in octogenarians: a need for intervention. J Intern Med. 2014 Jun;275(6):608-20. doi: 10.1111/joim.12174. Epub 2014 Mar 27.

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• Mylotte D, Osnabrugge RLJ, Windecker S, Lefevre T, de Jaegere P, Jeger R, Wenaweser P, Maisano F, Moat N, Sondergaard L, Bosmans J, Teles RC, Martucci G, Manoharan G, Garcia E, Van Mieghem NM, Kappetein AP, Serruys PW, Lange R, Piazza N. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013 Jul 16;62(3):210-219. doi: 10.1016/j.jacc.2013.03.074. Epub 2013 May 15.

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• Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P; FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011 Jan;32(2):191-7. doi: 10.1093/eurheartj/ehq261. Epub 2010 Sep 15.

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• 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.

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• Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, Lockowandt U. EuroSCORE II. Eur J Cardiothorac Surg. 2012 Apr;41(4):734-44; discussion 744-5. doi: 10.1093/ejcts/ezs043. Epub 2012 Feb 29.

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• Iung B, Laouenan C, Himbert D, Eltchaninoff H, Chevreul K, Donzeau-Gouge P, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Laskar M, Vahanian A, Gilard M; FRANCE 2 Investigators. Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score. Heart. 2014 Jul;100(13):1016-23. doi: 10.1136/heartjnl-2013-305314. Epub 2014 Apr 16.

  PMID: 24740804 BACKGROUND

• Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.

  PMID: 22922698 BACKGROUND

MeSH Terms

Conditions

Aortic Valve, Calcification of

Study Design

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

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share