Brief Title
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
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Mortality
Secondary Outcome
Stroke
Condition
Aortic Stenosis Symptomatic
Intervention
Transcatheter Aortic Valve Implantation
Study Arms / Comparison Groups
Symptomatic Severe Aortic Valve Stenosis
Description: Patients >18 years old with symptomatic severe aortic valve stenosis.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
500
Start Date
January 5, 2021
Completion Date
July 30, 2023
Primary Completion Date
December 30, 2022
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Vlad A Iliescu, MD PhD, +40773842692, [email protected]
Location Countries
Romania
Location Countries
Romania
Administrative Informations
NCT ID
NCT04694859
Organization ID
RO-TAVI
Responsible Party
Sponsor
Study Sponsor
Romanian Society of Cardiology
Study Sponsor
Vlad A Iliescu, MD PhD, Principal Investigator, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Verification Date
December 2020