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NCT Number: NCT03910751

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASZ Aalst, Aalst, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis

Device

Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis

Primary outcomes

  1. Primary safety endpoint

    Time frame: 30 days

    Composite of all-cause mortality, any stoke, VARC type 2-4 bleeding, acute kidney injury stage 3-4, major vascular, major access related, major cardiac structural complication, moderate or severe aortic regurgitation, new permanent pacemaker implantation and valve-related dysfunction requiring repeat procedure at 30 days

  2. Primary efficacy endpoint at 30 days

    Time frame: 30 days

    Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score <45 or decline from baseline >10 points at 30 days

  3. Primary efficacy endpoint at 1 year

    Time frame: 1 year

    Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score <45 or decline from baseline >10 points at 1 year

Secondary outcomes

  1. All-cause mortality

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  2. Stroke

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  3. Life threatening bleeding

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  4. Acute kidney injury

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  5. Coronary artery obstruction requiring intervention

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  6. Major vascular complication

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  7. Valve related dysfunction requiring repeat procedure

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  8. All-cause rehospitalization

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  9. Rehospitalization for valve-related symptoms or worsening congestive heart failure

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  10. New permanent pacemaker implantation

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  11. Myocardial infarction

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  12. NYHA heart failure class III or IV

    Time frame: 30 days and 1 year

    As defined by the most recent VARC document

  13. Patient reported Quality of Life

    Time frame: 30 days and 1 year

    As measured by the EQ5D-5L quality of life questionnaire

  14. Patient reported Quality of Life

    Time frame: 30 days and 1 year

    As measured by the KCCQ quality of life questionnaire

  15. Categorical cost analysis

    Time frame: 30 days

    Derived from length of stay on Intensive care unit and general ward

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: POLESTAR

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
Apr 10, 2019
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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