Closure of an opening in the septum between atria
Conditions
Interventions
Patients will receive 1) full-dose DOAC (rivaroxaban 20 mg q.d.) for 4 weeks
followed by SAPT until at least 6 months based on physician discretion, or 2)
our centers current standard of care, which
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - The subject is aged 18 years or older - The subject is scheduled for percutaneous closure of a PFO or ASD as indicated by the treating physician - The subject is able to understand and is willing to provide written informed consent to participate in the trial
Exclusion criteria
Exclusion criteria: - Unable or unwilling to return for required follow-up visits - High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical - Mechanical heart valves or valvular disease requiring surgery or interventional procedure - Ongoing major bleeding or complicated or recent (50 mmHg) or regurgitation grade 3 or more - Left ventricular ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will capture the following hemostatic endpoints: * Coagulation activation (e.g. prothrombin fragment 1+2, thrombin antithrombin III complex) * Platelet activation (e.g. P-selectin, CD40 ligand) * Von Willebrand Factor Antigen (VWF Ag) * Beta-thrombglobulin (beta-TG) * Plasminogen activator inhibitor-1 (PAI-1) * D-dimer * Thrombin Generation Test * Anti Xa activity Platelet function and thrombin generation testing will be performed in blood samples collected prior to the procedure, 7 days after the procedure and 3 months following the procedure. Blood samples will be obtained from venipuncture. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the primary hemostatic endpoints, secondary endpoints include clinical event rates of: * Ischemic stroke * Hemorrhagic stroke * Transient ischemic attack (TIA) * Systemic embolism (SE) * Pulmonary embolism (PE) * Device-related thrombus (DRT) * Major bleeding (according to BARC criteria), both procedural up to 7 days and total * Minor bleeding (according to BARC criteria), both procedural up to 7 days and total * All-cause and cardiovascular death * Incomplete device endothelialization * Composite of ischemic endpoints (ischemic stroke, TIA, SE, PE and DRT) * Composite of bleeding endpoints (major and minor bleeding and hemorrhagic stroke) | — |
Countries
Netherlands
Outcome results
None listed