NCT01959425

Oral Anticoagulation Therapy Pilot Study

Safety of Oral Anticoagulation Therapy Withdrawal After Successful Cardiac Ablation in Patients With Atrial Fibrillation and Associated High Risk Factors for Embolic Events (OAT Pilot Study)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.

Detailed description

Patients undergoing successful cardiac ablation for atrial fibrillation who remain AF recurrence-free 3 months after successful ablation and continue to meet the inclusion/exclusion criteria will be screened for enrollment in the trial. After fulfilling all of the inclusion/exclusion criteria, patients who consent to participate in the study and remain AF recurrence-free will be randomized to one of two study arms: (1) OAT Withdrawal (Test) Group or (2) OAT (Control) Group and participate in the Evaluation Period (12 months).

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	Off OAT Group (Test)	Discontinuation of OAT Therapy
OTHER	On OAT Group (Control)	Continuation of OAT Therapy

Timeline

• Start date: 2013-04-17
• Primary completion: 2019-10-07
• Completion: 2019-10-07
• First posted: 2013-10-10
• Last updated: 2025-02-04
• Results posted: 2020-12-17

Regulatory

• FDA-regulated drug study