Aortic Valve StenosisPOLESTARNCT03910751
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
An observational study of Aortic Valve Stenosis, run by Erasmus Medical Center at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
- Type of treatment
- Medical device
- How many people
- 252 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 1 Apr 2019to 24 Jan 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Eligible for ACURATE Neo valve implantation
- Patient agrees to follow-up duration
- Patient is able to understand and sign written informed consent
Who cannot join
- BMI > 35
- Pregnancy
- Cardiac
- Moderate to severely impaired left ventricular ejection fraction (LVEF <35%)
- Mitral regurgitation > moderate
- Pulmonary hypertension (sPAP > 60mmHg)
Show all 20Show fewer
- 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
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
Netherlands5 sites
University Medical Center Groningen
Groningen
Leiden University Medical Center
Leiden
St. Antonius Hospital
Nieuwegein
Erasmus University Medical Center
Rotterdam, 3015 GD
Utrecht University Medical Center
Utrecht
Belgium4 sites
ASZ Aalst
Aalst
AZ Sint-Jan Brugge
Bruges
UZ Brussel
Brussels
AZ Maria Middelares
Ghent
Canada3 sites
Royal Columbian Hospital
New Westminster
Sunnybrook Health Sciences Centre
Toronto
Vancouver General Hospital
Vancouver
United Kingdom3 sites
University Hospital Sussex NHS Foundation Trust
Brighton
Leeds Teaching Hospitals NHS Trust
Leeds
University Hospitals of Leicester NHS Trust
Leicester
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
- Keywords
- TAVI, TAVR, Early discharge, ACURATE Neo
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic BioprosthesisDevice
Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (15)
All-cause mortality
As defined by the most recent VARC document
Measured: 30 days and 1 year
Stroke
As defined by the most recent VARC document
Measured: 30 days and 1 year
Life threatening bleeding
As defined by the most recent VARC document
Measured: 30 days and 1 year
Acute kidney injury
As defined by the most recent VARC document
Measured: 30 days and 1 year
Coronary artery obstruction requiring intervention
As defined by the most recent VARC document
Measured: 30 days and 1 year
Major vascular complication
As defined by the most recent VARC document
Measured: 30 days and 1 year
Valve related dysfunction requiring repeat procedure
As defined by the most recent VARC document
Measured: 30 days and 1 year
All-cause rehospitalization
As defined by the most recent VARC document
Measured: 30 days and 1 year
Rehospitalization for valve-related symptoms or worsening congestive heart failure
As defined by the most recent VARC document
Measured: 30 days and 1 year
New permanent pacemaker implantation
As defined by the most recent VARC document
Measured: 30 days and 1 year
Myocardial infarction
As defined by the most recent VARC document
Measured: 30 days and 1 year
NYHA heart failure class III or IV
As defined by the most recent VARC document
Measured: 30 days and 1 year
Patient reported Quality of Life
As measured by the EQ5D-5L quality of life questionnaire
Measured: 30 days and 1 year
Patient reported Quality of Life
As measured by the KCCQ quality of life questionnaire
Measured: 30 days and 1 year
Categorical cost analysis
Derived from length of stay on Intensive care unit and general ward
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Apr 2019
- Primary completion5 Dec 2022
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
- Investigators
- Nicolas Van Mieghem, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910751
- Sponsor's protocol ID
- POLESTAR_EMC2019
- Acronym
- POLESTAR
- Status last verified
- Jun 2025
- First submitted
- 26 Mar 2019
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program
- ClinicalTrials.gov ID
- NCT03910751
- Acronym / sponsor ID
- POLESTAR / POLESTAR_EMC2019
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVI, TAVR, Early discharge, ACURATE Neo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Eligible for ACURATE Neo valve implantation
- Patient agrees to follow-up duration
- Patient is able to understand and sign written informed consent
Key exclusion criteria (20 listed)
- BMI > 35
- Pregnancy
- Cardiac
- Moderate to severely impaired left ventricular ejection fraction (LVEF <35%)
- Mitral regurgitation > moderate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic BioprosthesisTransfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis | Device | – |
Primary outcome
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
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
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
15 secondary outcomes
All-cause mortality
Time frame: 30 days and 1 year
Stroke
Time frame: 30 days and 1 year
Life threatening bleeding
Time frame: 30 days and 1 year
Acute kidney injury
Time frame: 30 days and 1 year
Coronary artery obstruction requiring intervention
Time frame: 30 days and 1 year
Major vascular complication
Time frame: 30 days and 1 year
Valve related dysfunction requiring repeat procedure
Time frame: 30 days and 1 year
All-cause rehospitalization
Time frame: 30 days and 1 year
Rehospitalization for valve-related symptoms or worsening congestive heart failure
Time frame: 30 days and 1 year
New permanent pacemaker implantation
Time frame: 30 days and 1 year
Myocardial infarction
Time frame: 30 days and 1 year
NYHA heart failure class III or IV
Time frame: 30 days and 1 year
Patient reported Quality of Life
Time frame: 30 days and 1 year
Patient reported Quality of Life
Time frame: 30 days and 1 year
Categorical cost analysis
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Van Mieghem, MD, PhD principal investigator
Erasmus Medical Center
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Erasmus Medical Center at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands, Belgium, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.