Thromboembolic, bleeding and vascular complications after transcatheter aortic valve implantation in patients using oral anticoagulants
Conditions
Interventions
Trade Name: Oral anticoagulants (acenocoumarol, phenprocoumon, rivaroxaban, apixaban, dabigatran, edoxaban)
Product Name: Oral anticoagulants (acenocoumarol, phenprocoumon, rivaroxaban, apixaban, dabi
Sponsors
St. Antonius Hospital Nieuwegein, The Netherlands
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. ;Timepoint(s) of evaluation of this end point: 30 days post procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Procedure related primary endpoints at 30 days. - Procedure related bleeding complications (type 1–4 bleeding ) at 30 days as defined by the VARC-3 criteria. - Procedure related thromboembolic complications (all stroke (except haemorrhagic), TIA, myocardial infarction, systemic embolism (vascular complications: distal embolization (non-cerebral) from a vascular source)) at 30 days as defined by the VARC-3 criteria. - Thromboembolic complications (all stroke (except haemorrhagic), TIA, myocardial infarction and systemic embolism (vascular complications: distal embolization (non-cerebral) from a vascular source)) at discharge and 30 days as defined by the VARC-3 criteria. - Neurologic events (overt CNS injury, covert CNS injury, neurologic dysfunction (acutely symptomatic) without CNS injury) at discharge and 30 days as defined by the VARC-3 criteria. - Cerebrovascular events (all stroke, TIA) at discharge and 30 days as defined by the VARC-3 criteria. - All stroke at discharge and 30 days as defined by the VARC-3 criteria. - Bleeding complications (type 1–4 bleeding) at discharge and 30 days as defined by the VARC-3 criteria. - Early safety at 30 days as defined by VARC-3 criteria, freedom from: all-cause mortality, all stroke, VARC type 2–4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device. Clinical efficacy at 30 days as defined by VARC-3 criteria, freedom from: all-cause mortality, all stroke, hospitalization for procedure- or valve related causes, KCCQ Overall Summary Score 10 point. - All-cause death at discharge and 30 days. - Cardiovascular death at discharge and 30 days. - Quality of life (assessed by SF-12, KCCQ, and TASQ) at 30 days and 90 days.;Timepoint(s) of evaluation of this end point: 30 days post-procedur | — |
Countries
Belgium, Denmark, Italy
Contacts
Public ContactR&I Heart Center
St. Antonius Hospital
Outcome results
None listed