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

NCT03910751 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 252

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis

Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis

Sponsors & Collaborators

Principal Investigators

  • Nicolas Van Mieghem, MD, PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-12-05
Completion
2024-01-24
FDA Device
Yes

Countries

  • Belgium
  • Canada
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03910751 on ClinicalTrials.gov