CompletedNo phase
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
Key facts
- Who runs it
- Erasmus Medical Center
- Where
- Belgium, Canada, Netherlands, and United Kingdom15 sites in 4 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 252 people enrolled
- Started
- 1 Apr 2019
- Ended
- 24 Jan 2024
- Type of study
- Observational
- Treatments tested
- Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
- Record updated
- 23 July 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Eligible for ACURATE Neo valve implantation
- Patient agrees to follow-up duration
- Patient is able to understand and sign written informed consent
Who cannot take part
- Pregnancy; Cardiac
- Pulmonary hypertension (sPAP > 60mmHg)
- No complex coronary artery disease
- Presence of severe peripheral artery disease
- Moderate to severely impaired left ventricular ejection fraction (LVEF <35%)
- GFR < 35ml/min; Frailty
- BMI > 35
- Mitral regurgitation > moderate
- Untreated high degree AV-block or RBBB; Pulmonary
- COPD Gold > 2; Kidney function
- Inappropriate social support and/or (familial) care
- Patient is walking aid dependent; TAVI strategy
- Transfemoral approach not possible; Follow up
- Inability to adhere to follow-up
This trial has no sites in United States.
It has sites in 4 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Treatments tested
- Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program
- Record updated
- 23 July 2025