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
MedDRA version: 22.1Level: LLTClassification code 10057613Term: Thromboembolic strokeSystem Organ Class: 100000004852
MedDRA version: 21.1Level: LLTClassification code 10043565Term: Thromboembolic eventSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2020-001817-20-DK

Lead Sponsor: St. Antonius Hospital Nieuwegein, The Netherlands

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 858

Inclusion Criteria

Planned transfemoral or transsubclavian TAVI procedure
Uses oral anti-coagulation at screening
Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of periprocedurally continued versus interrupted oral anticoagulants in patients undergoing transcatheter aortic valve implantation;Secondary Objective: Evaluate quality of life<br>Evaluate cost-effectiveness;Primary end point(s): A composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding complications at 30 days after TAVI as defined by the VARC-3 criteria.<br><br>;Timepoint(s) of evaluation of this end point: 30 days post procedure

Secondary Outcome Measures