Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
NCT ID: NCT04694859
Last Updated: 2021-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2021-01-05
2023-07-30
Brief Summary
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Detailed Description
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Objective: This is a national quality assurance initiative to improve patient care and outcomes. It further serves as a database for the assessment of the safety and efficacy of TAVI and its financial implications (e.g. reimbursement).
Design: National, prospective, observational, multi-center registry. All centers performing TAVI in Romania; minimum cases per center for inclusion: 20 cases/year-to-date Population: All patients undergoing TAVI in Romania at any of the participating centers with a CE-marked valve of any manufacturer given that they provide written informed consent.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Symptomatic Severe Aortic Valve Stenosis
Patients \>18 years old with symptomatic severe aortic valve stenosis.
Transcatheter Aortic Valve Implantation
Transfemoral or transapical Transcatheter Aortic Valve Implantation
Interventions
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Transcatheter Aortic Valve Implantation
Transfemoral or transapical Transcatheter Aortic Valve Implantation
Eligibility Criteria
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Inclusion Criteria
* high risk or patients deemed amenable for TAVI by a multidisciplinary team
* signed informed consent to participate in the study
Exclusion Criteria
* left ventricle thrombus
* active endocarditis
* high risk of coronary ostium obstruction
* plaques with mobile thrombi in the ascending aorta, or arch
* hemodynamic instability
* estimated life expectancy \<1 year
* comorbidity suggesting lack of improvement of quality of life
* other situations adjudicated by the local HeartTeam
18 Years
ALL
No
Sponsors
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Romanian Society of Cardiology
OTHER
Responsible Party
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Principal Investigators
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Vlad A Iliescu, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Bogdan A Popescu, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Dragos Vinereanu, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Locations
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Catalina A. Parasca, MD
Bucharest, , Romania
Countries
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Central Contacts
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Facility Contacts
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References
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Lindroos M, Kupari M, Heikkila J, Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993 Apr;21(5):1220-5. doi: 10.1016/0735-1097(93)90249-z.
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.
Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.
Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1.
Iung B, Delgado V, Rosenhek R, Price S, Prendergast B, Wendler O, De Bonis M, Tribouilloy C, Evangelista A, Bogachev-Prokophiev A, Apor A, Ince H, Laroche C, Popescu BA, Pierard L, Haude M, Hindricks G, Ruschitzka F, Windecker S, Bax JJ, Maggioni A, Vahanian A; EORP VHD II Investigators. Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey. Circulation. 2019 Oct;140(14):1156-1169. doi: 10.1161/CIRCULATIONAHA.119.041080. Epub 2019 Sep 12.
Other Identifiers
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RO-TAVI
Identifier Type: -
Identifier Source: org_study_id
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