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

Romanian Society of Cardiology

Status: Unknown

Conditions: Aortic Stenosis Symptomatic; Aortic Valve Stenosis

Treatments: Device: Transcatheter Aortic Valve Implantation

Study type: Observational

Funder types: Other

Identifiers

NCT04694859

RO-TAVI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Symptomatic Severe Aortic Valve Stenosis

Description:

Patients \>18 years old with symptomatic severe aortic valve stenosis.

Treatment:

Device: Transcatheter Aortic Valve Implantation