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