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Clinical Trials/EUCTR2020-001817-20-NL
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

Sponsor
St. Antonius Hospital Nieuwegein, The Netherlands

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Periprocedural continuation versus... | Clinical Trial