Clinical trial NCT04694859: Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
Official title: Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis Symptomatic
Aortic Valve Stenosis
Keywords: aortic stenosis
Lead sponsor: Romanian Society of Cardiology
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old diagnosed with symptomatic severe aortic valve stenosis undergoing TAVI.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 1-year
Secondary outcomes:
measure: Stroke
timeFrame: 1-year
measure: Bleeding
timeFrame: 1-year
measure: Myocardial ischemia
timeFrame: 1-year
measure: Arrhythmia
timeFrame: 1-year
measure: Vascular complications
timeFrame: 1-year
measure: Acute kidney injury
timeFrame: 1-year
Other outcomes:
Locations:
city: Bucuresti
country: Romania
facility: Catalina A. Parasca, MD
Study officials:
affiliation: University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
name: Vlad A Iliescu, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
name: Bogdan A Popescu, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
name: Dragos Vinereanu, MD PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
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