DAPPAR AF Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation (DAPPARAF)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation|
- The incidence of peri-procedural major bleeding complications [ Time Frame: 1 month prior to Pulmonary Vein Ablation and three months post ablation. ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Dabigatran
Dabigatran will be compared to historical data using other OAC methods for Pulmonary Vein Ablation
30 days pre ablation and 90 days post ablation
Other Name: pradax
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468155
|London Health Sciences Center||Recruiting|
|London, Ontario, Canada, N6A 5A5|
|Contact: Allan Skanes, M.D. FRCP 519-663-3746 email@example.com|
|Contact: Cathy Bentley, BScN 519-685-8500 ext 32835 firstname.lastname@example.org|
|Principal Investigator: Allan c Skanes, MD FRCP|
|Principal Investigator: Allan c Skanes, M.D. FRCP|
|Principal Investigator:||Allan Skanes, MD, FRCPC||Lawson Health Research Institute|