Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate major adverse bleeding risks, and thromboembolic event rates post radiofrequency (RF) ablation. The primary goal is to establish safety of dabigatran use for peri-procedural anti-coagulation after left atrial catheter radiofrequency ablation, or cryoablation procedures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Boehringer Ingelheim
• Treatments: Dabigatran

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