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.
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
500
Transfemoral or transapical Transcatheter Aortic Valve Implantation
Catalina A. Parasca, MD
Bucharest, Romania
RECRUITINGMortality
All cause mortality
Time frame: 1-year
Stroke
Ischemic or hemorrhagic cerebrovascular accident
Time frame: 1-year
Bleeding
Major bleeding
Time frame: 1-year
Myocardial ischemia
Acute myocardial infarction or recurrent angina
Time frame: 1-year
Arrhythmia
Arrhythmias requiring permanent pacemaker implantation
Time frame: 1-year
Vascular complications
Procedure related vascular complications
Time frame: 1-year
Acute kidney injury
Procedure related renal dysfunction
Time frame: 1-year
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