Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis – RO-TAVI

Overview

RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.

Full Title of Study: “Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis – RO-TAVI”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 30, 2022

Detailed Description

Background: Since the establishment of transcatheter aortic valve implantation (TAVI) in Romania in 2015 there has been a growing number of interventions being performed by an increasing number of hospitals throughout the country. In 2018, there were more than 250 implants, which are expected to grow in the following years by about 30% on an annual basis. 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.

Interventions

  • Device: Transcatheter Aortic Valve Implantation
    • Transfemoral or transapical Transcatheter Aortic Valve Implantation

Arms, Groups and Cohorts

  • Symptomatic Severe Aortic Valve Stenosis
    • Patients >18 years old with symptomatic severe aortic valve stenosis.

Clinical Trial Outcome Measures

Primary Measures

  • Mortality
    • Time Frame: 1-year
    • All cause mortality

Secondary Measures

  • Stroke
    • Time Frame: 1-year
    • Ischemic or hemorrhagic cerebrovascular accident
  • Bleeding
    • Time Frame: 1-year
    • Major bleeding
  • Myocardial ischemia
    • Time Frame: 1-year
    • Acute myocardial infarction or recurrent angina
  • Arrhythmia
    • Time Frame: 1-year
    • Arrhythmias requiring permanent pacemaker implantation
  • Vascular complications
    • Time Frame: 1-year
    • Procedure related vascular complications
  • Acute kidney injury
    • Time Frame: 1-year
    • Procedure related renal dysfunction

Participating in This Clinical Trial

Inclusion Criteria

  • severe symptomatic aortic valve stenosis – high risk or patients deemed amenable for TAVI by a multidisciplinary team – signed informed consent to participate in the study Exclusion Criteria:

  • inadequate annulus size (<18 mm, >29 mm) – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Romanian Society of Cardiology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vlad A Iliescu, MD PhD, Principal Investigator, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania
    • Bogdan A Popescu, MD PhD, Principal Investigator, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania
    • Dragos Vinereanu, MD PhD, Principal Investigator, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania
  • Overall Contact(s)
    • Catalina A Parasca, MD, +40773842692, catalina.parasca@gmail.com

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.