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

Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - 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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis

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.

• Study Type: Observational
• Enrollment (Actual): 252

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • ASZ Aalst
  • Brugge, Belgium
    • AZ Sint-Jan Brugge
  • Brussel, Belgium
    • UZ Brussel
  • Gent, Belgium
    • AZ Maria Middelares
• Canada
  • New Westminster, Canada
    • Royal Columbian Hospital
  • Toronto, Canada
    • Sunnybrook Health Sciences Centre
  • Vancouver, Canada
    • Vancouver General Hospital
• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Leiden, Netherlands
    • Leiden University Medical Center
  • Nieuwegein, Netherlands
    • St. Antonius Hospital
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus University Medical Center
  • Utrecht, Netherlands
    • Utrecht University Medical Center
• United Kingdom
  • Brighton, United Kingdom
    • University Hospital Sussex NHS foundation Trust
  • Leeds, United Kingdom
    • Leeds Teaching Hospitals NHS Trust
  • Leicester, United Kingdom
    • University Hospitals of Leicester NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

250 patients with severe AS and selected for TF-TAVI with the ACURATE Neo valve and eligible for early discharge within 48 hours post TAVI

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety endpoint	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	30 days
Primary efficacy endpoint at 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	30 days
Primary efficacy endpoint at 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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	As defined by the most recent VARC document	30 days and 1 year
Stroke	As defined by the most recent VARC document	30 days and 1 year
Life threatening bleeding	As defined by the most recent VARC document	30 days and 1 year
Acute kidney injury	As defined by the most recent VARC document	30 days and 1 year
Coronary artery obstruction requiring intervention	As defined by the most recent VARC document	30 days and 1 year
Major vascular complication	As defined by the most recent VARC document	30 days and 1 year
Valve related dysfunction requiring repeat procedure	As defined by the most recent VARC document	30 days and 1 year
All-cause rehospitalization	As defined by the most recent VARC document	30 days and 1 year
Rehospitalization for valve-related symptoms or worsening congestive heart failure	As defined by the most recent VARC document	30 days and 1 year
New permanent pacemaker implantation	As defined by the most recent VARC document	30 days and 1 year
Myocardial infarction	As defined by the most recent VARC document	30 days and 1 year
NYHA heart failure class III or IV	As defined by the most recent VARC document	30 days and 1 year
Patient reported Quality of Life	As measured by the EQ5D-5L quality of life questionnaire	30 days and 1 year
Patient reported Quality of Life	As measured by the KCCQ quality of life questionnaire	30 days and 1 year
Categorical cost analysis	Derived from length of stay on Intensive care unit and general ward	30 days

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Nicolas Van Mieghem, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: TAVI; Early discharge; TAVR; ACURATE Neo
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: POLESTAR_EMC2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No