Atrial septal defect or patent foramen ovale indicated for percutaneous closure with an occluder device.
Conditions
Interventions
Trade Name: Plavix
Pharmaceutical Form: Tablet
Trade Name: Acetylsalicylylzuur Cardio (and others)
Pharmaceutical Form: Tablet
Trade Name: Xarelto
Pharmaceutical Form: Tablet
Sponsors
St. Antonius Hospital
Eligibility
Sex/Gender
All
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 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 47 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
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 <30% - Life expectancy of less than 1 year - Any indication for long-term oral anticoagulation other than presence/closure of a PFO/ASD (such as atrial fibrillation) - Any indication for long-term (dual) antiplatelet therapy other than presence/closure of a PFO/ASD (such as recent coronary stenting) - Contraindication for the use of rivaroxaban or DAPT (e.g. history of intracranial bleeding) in the investigator's opinion - Pregnant or planning to become pregnant during the time of the study - Estimated glomerular filtration rate <50 ml/min/1.73m2 - Use of medication that significantly interacts with rivaroxaban; medication that inhibits cytochrome P450 3A4 or P-glycoprotein (such as ketoconazole, human immunodeficiency virus (HIV) protease inhibitors, clarithromycin, erythromycin and fluconazole) or induces cytochrome P450 3A4 (such as rifampicin and several anti-epileptic drugs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of the study is to evaluate hemostasis, such as coagulation activation, thrombin generation and platelet reactivity following catheter-based closure of patent foramen ovale or atrial septal defect. Differences between post-procedural regimen (i.e. DAPT and rivaroxaban) will be assessed in the current pilot study. ;Secondary Objective: In addition to the hemostasis parameters, secondary (clinical) endpoints during 12-month follow-up will include: •Rate of device-related thrombus (DRT) •Rate of stroke, TIA, systemic embolism, pulmonary embolism and (cardiovascular) death •Rate of minor and major bleeding •Incomplete device endothelialization ;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: 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 |
|---|---|
| Secondary end point(s): 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) ;Timepoint(s) of evaluation of this end point: Occurrence of clinical endpoints will be assessed during 3-month and 12-month follow up visits. | — |
Countries
Netherlands
Contacts
Public ContactResearch & Innovation Cardiology
St. Antonius Hospital
Outcome results
None listed