NCT03910751

POLESTAR Trial - An International Multi-center Early Discharge TAVI Program

Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 252 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.

Detailed description

In this International multi-center prospective observational study, 250 patients with severe symptomatic aortic stenosis (AS) and eligibility for transfemoral TAVI with ACURATE Neo Bioprosthesis, will be pre-procedurally selected for participation in an early discharge protocol in which patients are discharged within 48 hours after uncomplicated TAVI.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis	Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-12-05
• Completion: 2024-01-24
• First posted: 2019-04-10
• Last updated: 2025-07-23

Locations

15 sites across 4 countries: Belgium, Canada, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study