Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli "PARADOX"


Phase 2 Results N/A

Eligibility Criteria

- A clinical indication for a trans venous pacemaker, ICD, or CRT device, or presence of a pre-existing endovascular CIED
- Presence of a PFO (regardless of shunt direction) confirmed with trans-esophageal or trans-thoracic echocardiography with color flow Doppler and/or agitated saline
- Absence of any contraindication for anticoagulation
- Absence of a clinical indication for systemic anticoagulation
- Ability to give informed consent for the trial
- Able to undergo head MRI and consent for MRI study to be performed in presence of CIED
- Patients with a survival expectancy of less than one year
- Patients who require systemic anticoagulation for any established clinical indication (excluding the presence of PFO with CIED)
- Patients with an atrial or ventricular septal defect that is hemodynamically significant and requires repair as suggested by the ACC/AHA 2008 guidelines on evaluation and treatment of adult congenital heart diseases
- Absence of a CIED or no clinical indication for a trans venous CIED
- Contraindication to undergoing an MRI
- Patients with an active infection that cannot be treated successfully prior to randomization
- Women who are pregnant or breastfeeding, or women of child-bearing potential who do not wish to use an effective method of birth control during the course of study in a manner such that the risk of failure is minimized
- Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
- Known sensitivity to any of the active substances or their excipients to be administered during dosing with study medication