Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

Active, not recruiting

Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male or female sex, age 18-85 years.
- Negative pregnancy test for women of childbearing potential
- Planned pulmonary vein isolation by antral radiofrequency or cryoablation for paroxysmal or persistent atrial fibrillation, non-valvular atrial fibrillation (NVAF), or left atrial flutter following prior left atrial ablation procedures
- CHADS2 score of 0-6 or CHADS2-VASc score 0-9
- Vascular hemostasis within 4-6 hours of sheath pull
- Able to give informed consent

Exclusion Criteria

- Unable to give informed consent
- Currently participating in another clinical treatment trial
- History of hereditary hemophilias
- Presence of active bleeding
- End stage renal disease, CrCl<15 mL/min
- Prior treatment failure of dabigatran (stroke or systemic thromboembolism while on therapeutic dabigatran)
- Known allergic reaction to dabigatran etexilate
- Intolerance to dabigatran, if medication naïve, or other contra-indications as per the USPI.
- Pregnancy
- History of non-compliance
- Inability to follow-up