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

Aortic Valve Stenosis Clinical Trial

— RO-TAVI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694859
• Other study ID #: RO-TAVI
• Status: Recruiting
• Start date: January 5, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: December 2020
• Source: Romanian Society of Cardiology
• Contact: Catalina A Parasca, MD
• Phone: +40773842692
• Email: catalina.parasca[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis Symptomatic
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
Romania	Catalina A. Parasca, MD	Bucuresti

Sponsors (1)

Lead Sponsor	Collaborator
Romanian Society of Cardiology

Country where clinical trial is conducted

Romania, 

References & Publications (5)

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, Piérard 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. — View Citation

Kappetein AP, Head SJ, Généreux 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, Rodés-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. — View Citation

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. — View Citation

Lindroos M, Kupari M, Heikkilä 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. — View Citation

Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schäfers 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All cause mortality	1-year
Secondary	Stroke	Ischemic or hemorrhagic cerebrovascular accident	1-year
Secondary	Bleeding	Major bleeding	1-year
Secondary	Myocardial ischemia	Acute myocardial infarction or recurrent angina	1-year
Secondary	Arrhythmia	Arrhythmias requiring permanent pacemaker implantation	1-year
Secondary	Vascular complications	Procedure related vascular complications	1-year
Secondary	Acute kidney injury	Procedure related renal dysfunction	1-year