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

Last updated: October 25, 2023
Sponsor: Erasmus Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis

Clinical Study ID

NCT03910751
POLESTAR_EMC2019
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible for ACURATE Neo valve implantation
  • Patient agrees to follow-up duration
  • Patient is able to understand and sign written informed consent

Exclusion

Exclusion Criteria:

  • BMI > 35
  • Pregnancy Cardiac
  • Moderate to severely impaired left ventricular ejection fraction (LVEF <35%)
  • Mitral regurgitation > moderate
  • Pulmonary hypertension (sPAP > 60mmHg)
  • No complex coronary artery disease
  • Untreated high degree AV-block or RBBB Pulmonary
  • COPD Gold > 2 Kidney function
  • GFR < 35ml/min Frailty
  • Inappropriate social support and/or (familial) care
  • Patient is walking aid dependent TAVI strategy
  • Presence of severe peripheral artery disease
  • Transfemoral approach not possible Follow up
  • Inability to adhere to follow-up

Study Design

Total Participants: 252
Treatment Group(s): 1
Primary Treatment: Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
Phase:
Study Start date:
April 01, 2019
Estimated Completion Date:
February 01, 2024

Study 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.

Connect with a study center

  • ASZ Aalst

    Aalst,
    Belgium

    Site Not Available

  • AZ Sint-Jan Brugge

    Brugge,
    Belgium

    Site Not Available

  • UZ Brussel

    Brussel,
    Belgium

    Site Not Available

  • AZ Maria Middelares

    Gent,
    Belgium

    Site Not Available

  • Royal Columbian Hospital

    New Westminster,
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto,
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver,
    Canada

    Site Not Available

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen,
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Site Not Available

  • St. Antonius Hospital

    Nieuwegein,
    Netherlands

    Site Not Available

  • Erasmus University Medical Center

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Utrecht University Medical Center

    Utrecht,
    Netherlands

    Site Not Available

  • Linköping University Hospital

    Linköping,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • University Hospital Sussex NHS Foundation Trust

    Brighton,
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust

    Leeds,
    United Kingdom

    Site Not Available

  • University Hospitals of Leicester NHS Trust

    Leicester,
    United Kingdom

    Site Not Available

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