Conditions: Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 678
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.

Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.

It is not intended to assess confirmatory hypothesis, this is an exploratory study.

Detailed description:

Arms:
arm 1: Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID) arm 2: Patients receiving Warfarin to keep International Normalized Ratio (INR) between 2.0 - 3.0

Interventions: intervention 1: Warfarin intervention 2: Dabigatran Etexilate 150mg
Intervention descriptions: intervention 1: Patients receiving Warfarin to keep International Normalized Ratio (INR)between 2.0 - 3.0 intervention 2: Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)

Protocol document: