EUCTR2020-001817-20-NLActive, not recruitingPhase 1
Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation - PAUSE TAVI trial
St. Antonius Hospital Nieuwegein, The Netherlands0 sites858 target enrollmentStarted: October 29, 2020Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 858
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Planned transfemoral transcatheter aortic valve implantation procedure
- •Uses oral anti-coagulation at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 808
Exclusion Criteria
- •Patients at high risk for thromboembolism for who interruption of oral anticoagulants is no option, i.e.:
- •-Mechanical heart valve
- •-Intracardiac thrombus
- •-< 3 months after venous thromboembolism
- •-< 6 months after TIA/stroke in patients with atrial fibrillation
Investigators
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