Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry

Medical University of Warsaw

Status: Enrolling

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency; Ventricular Outflow Obstruction, Left

Treatments: Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)

Study type: Observational

Funder types: Other

Identifiers

NCT03361046

WUM-VIV

Details and patient eligibility

About

In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

Full description

The study is a prospective multicenter evaluation of transcatheter aortic valve-in-valve implantations in Polish health centers.

Duration of this study is expected to be 6 years to ensure that all of the enrolled patients will complete at least 2 years of follow-up.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Failing surgically implanted aortic bioprosthetic valve (stented/stentless/homograft) demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Qualification for TAVI by decision of the local Heart Team
• Patient provided written informed consent

Trial design

150 participants in 1 patient group

Transcatheter Aortic Valve-in-Valve Implantation Cohort

Treatment:

Device: Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)