Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to explore the risk of periprocedural thromboembolic events in continuous versus interrupted Coumadin therapy in a large, randomized high-risk patient population undergoing radio-frequency catheter ablation for atrial fibrillation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Collaborators: California Pacific Medical Center; Case Western Reserve University; Catholic University, Italy; Southlake Regional Health Centre; Stanford University; University of Kansas
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Warfarin

Criteria

Inclusion Criteria:

1. Age- 18-75 years

2. Patients in paroxysmal, persistent or long-standing persistent (LSP) AF

3. patients with CHADS2 score ≥ 1

4. AF patients with INR in the range of 2.0-3.0 in the last 3-4 weeks prior to ablation

Exclusion Criteria:

1. Patients with known bleeding disorders or inherited thrombophilic disorder

2. Patients with oral contraceptives or estrogen replacement therapy

3. Patients with prosthetic heart valves

4. Patients unable or willing to give informed consent

5. Contraindications for Coumadin therapy

6. Patients with CHADS2 score zero

7. Contraindication to undergoing an MRI