POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
NCT ID: NCT03910751
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
252 participants
OBSERVATIONAL
2019-04-01
2024-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis
Eligibility Criteria
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Inclusion Criteria
* Patient agrees to follow-up duration
* Patient is able to understand and sign written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Erasmus Medical Center
OTHER
Responsible Party
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Nicolas van Mieghem
Principal Investigator
Principal Investigators
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Nicolas Van Mieghem, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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ASZ Aalst
Aalst, , Belgium
AZ Sint-Jan Brugge
Bruges, , Belgium
UZ Brussel
Brussels, , Belgium
AZ Maria Middelares
Ghent, , Belgium
Royal Columbian Hospital
New Westminster, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
Vancouver General Hospital
Vancouver, , Canada
University Medical Center Groningen
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Utrecht University Medical Center
Utrecht, , Netherlands
University Hospital Sussex NHS Foundation Trust
Brighton, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Countries
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Other Identifiers
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POLESTAR_EMC2019
Identifier Type: -
Identifier Source: org_study_id
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