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 anticoagulantsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-001817-20-IT
- Lead Sponsor
- ST. ANTONIUS HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 858
Inclusion Criteria
Planned percutaneous transcatheter aortic valve implantation 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) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 858
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 peri-procedurally continued versus interrupted oral anticoagulants in patients undergoing transcatheter aortic valve implantations;Secondary Objective: Evaluate quality of life<br>Evaluate cost-effectiveness;Primary end point(s): A composite of cardiovascular mortality, all stroke, myocardial<br>infarction, major vascular complications and type 2-4 bleeding<br>complications at 30 days after TAVI as defined by the VARC-3 criteria.;Timepoint(s) of evaluation of this end point: 30 days post procedure
- Secondary Outcome Measures
Name Time Method