Periprocedural continuation versus interruption of blood thinners during transcatheter aortic valve implantatio

Phase 1

• Conditions: Thromboembolic, bleeding and vascular complications after transcatheter aortic valve implantation in patients using oral anticoagulants; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-001817-20-NL
• Lead Sponsor: St. Antonius Hospital Nieuwegein, The Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-29
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 858

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified