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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Aortic Stenosis Symptomatic
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Catalina A Parasca, MD; Phone Number: +40773842692; Email: catalina.parasca@gmail.com
• Study Contact Backup: Name: Bogdan A Popescu, MD PhD; Phone Number: +40722611305; Email: bogdan.a.popescu@gmail.com

Study Locations

• Romania
  • Bucuresti, Romania, 030423
    • Recruiting
    • Catalina A. Parasca, MD
    • Contact: Catalina A Parasca, MD; Phone Number: +40773842692; Email: catalina.parasca@gmail.com
    • Contact: Vlad A Iliescu, MD PhD; Phone Number: +40722244055; Email: vladanton.iliescu@gmail.com
    • Sub-Investigator: Dan Deleanu, MD PhD
    • Sub-Investigator: Ovidiu Chioncel, MD PhD
    • Sub-Investigator: Stefan Mot, MD PhD
    • Sub-Investigator: Cristian Udroiu, MD
    • Sub-Investigator: Horatiu Moldovan, MD PhD
    • Sub-Investigator: Grigore Tinica, MD PhD
    • Sub-Investigator: Horatiu Suciu, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old diagnosed with symptomatic severe aortic valve stenosis undergoing TAVI.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Symptomatic Severe Aortic Valve Stenosis; Patients >18 years old with symptomatic severe aortic valve stenosis.	Device: Transcatheter Aortic Valve Implantation; Transfemoral or transapical Transcatheter Aortic Valve Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All cause mortality	1-year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Romanian Society of Cardiology
• Investigators: Principal Investigator: Vlad A Iliescu, MD PhD, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania; Principal Investigator: Bogdan A Popescu, MD PhD, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania; Principal Investigator: Dragos Vinereanu, MD PhD, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 5, 2021
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): July 30, 2023

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (ACTUAL): January 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: aortic stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: RO-TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No