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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2023
  • participants needed
    500
  • sponsor
    Romanian Society of Cardiology
Updated on 26 January 2021

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.

Details
Condition Aortic Stenosis, VALVULAR HEART DISEASE, Heart Valve Disease, Symptomatic Aortic Stenosis, Aortic Stenosis Symptomatic, Heart Valve Disease, aortic valve stenosis
Treatment Transcatheter Aortic Valve Implantation
Clinical Study IdentifierNCT04694859
SponsorRomanian Society of Cardiology
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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