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

Completed · Phase 3

Conditions studied: Thromboembolism

In brief

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.

Key facts

Study ID

NCT01006876

Run by

Texas Cardiac Arrhythmia Research Foundation

People needed

1584

Starts

2010-01-01

Expected to finish

2014-04-01

Last updated by the study team

2015-05-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age- 18-75 years
• Patients in paroxysmal, persistent or long-standing persistent (LSP) AF
• patients with CHADS2 score ≥ 1
• AF patients with INR in the range of 2.0-3.0 in the last 3-4 weeks prior to ablation

You may not qualify if…

• Patients with known bleeding disorders or inherited thrombophilic disorder
• Patients with oral contraceptives or estrogen replacement therapy
• Patients with prosthetic heart valves
• Patients unable or willing to give informed consent
• Contraindications for Coumadin therapy
• Patients with CHADS2 score zero
• Contraindication to undergoing an MRI

Where it is running

• St.David's Medical Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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