Status:
COMPLETED
Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
Lead Sponsor:
St. Antonius Hospital
Conditions:
Aortic Valve Disease
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% ...
Eligibility Criteria
Inclusion
- Planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure
- Uses oral anticoagulation at screening
- Provided written informed consent
Exclusion
- Patients at high risk for thromboembolism for whom interruption of oral anticoagulants is no option, i.e.:
- Mechanical heart valve prosthesis
- Intracardiac thrombus
- \< 3 months after venous thromboembolism
- \< 6 months after transient ischemic attack or stroke in patients with atrial fibrillation
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
858 Patients enrolled
Trial Details
Trial ID
NCT04437303
Start Date
November 25 2020
End Date
May 22 2024
Last Update
May 31 2024
Active Locations (22)
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1
A.S.Z. Hospital
Aalst, Belgium
2
O.L.V. Hospital
Aalst, Belgium
3
ZNA Middelheim
Antwerp, Belgium
4
AZ Sint-Jan
Bruges, Belgium