Status:
UNKNOWN
Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
Lead Sponsor:
Romanian Society of Cardiology
Conditions:
Aortic Stenosis Symptomatic
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
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...
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 hos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04694859
Start Date
January 5 2021
End Date
July 30 2023
Last Update
January 5 2021
Active Locations (1)
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1
Catalina A. Parasca, MD
Bucharest, Romania, 030423