NCT03361046

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

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve-in-Valve Implantation in Polish Population - Observational Multicenter Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Insufficiency
• Ventricular Outflow Obstruction, Left

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)	Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-12-31
• Completion: 2024-05-30
• First posted: 2017-12-04
• Last updated: 2020-10-22

Locations

12 sites across 1 country: Poland

Regulatory

• FDA-regulated device study