DAPPAR AF Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation — DAPPARAF  

Atrial Fibrillation Clinical Trial

Official title: Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation

Status Completed

Clinical Trial Summary

It is hypothesized that peri-ablation Dabigatran will be a safe and effective method of peri-procedural anticoagulation for Atrial Fibrillation (AF) ablation, resulting in a low rate of peri-procedural bleeding and thromboembolic complications.

Clinical Trial Description

All patients will be initiated on fixed dose Dabigatran 150 mg BID at least one month prior to the ablation procedure. If patients were already on warfarin therapy, then warfarin should be stopped for a minimum of 2 days prior to Dabigatran initiation, when the INR is less than

2. Patients will remain on the same dose of Dabigatran until the day before ablation. On the day prior to ablation, patients will not take any Dabigatran, nor will any be taken on the day of ablation, until after sheath removal.

For patients in high-risk groups for bleeding, the lower dose of Dabigatran may be used, or the drug may be stopped further in advance of the procedure. For patients with age greater than 80 years old, the lower dose of Dabigatran (110 mg BID) may be used as an alternative. For patients with impaired renal function, the lower dose may be used, but the drug may be stopped earlier in advance of the procedure as per the suggestions in Appendix A.

Post-ablation, Dabigatran will be started at the same dose - either 150 mg or 110 mg - as before the ablation procedure. Dabigatran will be initiated 8 hours post sheath removal and continue twice daily until the three month follow-up. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT01468155
• Study type: Interventional
• Source: Lawson Health Research Institute
• Status: Completed
• Phase: Phase 4
• Start date: July 13, 2011
• Completion date: June 7, 2017