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

July 18, 2025 updated by: Nicolas van Mieghem, Erasmus Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 days
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
30 days
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
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
Stroke
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
Life threatening bleeding
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
Acute kidney injury
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
Coronary artery obstruction requiring intervention
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
Major vascular complication
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
Valve related dysfunction requiring repeat procedure
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
All-cause rehospitalization
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
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
30 days and 1 year
New permanent pacemaker implantation
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
Myocardial infarction
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
NYHA heart failure class III or IV
Time Frame: 30 days and 1 year
As defined by the most recent VARC document
30 days and 1 year
Patient reported Quality of Life
Time Frame: 30 days and 1 year
As measured by the EQ5D-5L quality of life questionnaire
30 days and 1 year
Patient reported Quality of Life
Time Frame: 30 days and 1 year
As measured by the KCCQ quality of life questionnaire
30 days and 1 year
Categorical cost analysis
Time Frame: 30 days
Derived from length of stay on Intensive care unit and general ward
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas Van Mieghem, MD, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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