Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantatio

Phase 4

Recruiting

• Conditions: TAVI; transcatheter aortic valve implantation; 10046973

• Registration Number: NL-OMON56111
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 778

Inclusion Criteria

• Planned transfemoral or transsubclavian TAVI procedure
• Uses oral anticoagulation at screening
• Provided written informed consent

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A composite of cardiovascular mortality, all stroke, myocardial infarction,<br /><br>major vascular complications and type 2-4 bleeding complications at 30 days<br /><br>post TAVI as defined by the VARC-3 criteria.</p><br>