NCT04694859

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Romanian Society of Cardiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis Symptomatic
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation	Transfemoral or transapical Transcatheter Aortic Valve Implantation

Timeline

• Start date: 2021-01-05
• Primary completion: 2022-12-30
• Completion: 2023-07-30
• First posted: 2021-01-05
• Last updated: 2021-01-05

Locations

1 site across 1 country: Romania

Regulatory

• FDA-regulated device study