Safe Use of New Oral Anticoagulants in Ablation for Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02569255
• Lead Sponsor: Private Hospital Heart Center Varde

Brief Summary

Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All complications possible being related to the use of NOAC are registered.

Detailed Description

Use of new oral anticoagulants (NOAC) in patients before and after radiofrequency ablation with pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients paused their NOAC treatment for 24 hours before ablation. Patients were routinely followed up after 3 months with a standard formular focused on possible adverse events (major bleeding complications or thromboembolic events) to NOAC treatment. Adverse events related to the use of NOAC were registered during treatment or during 3 months of follow-up.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-02
• Last Update Submitted: 2015-10-02
• Study First Posted: 2015-10-06
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• Symptomatic atrial fibrillation despite pharmacological treatment.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with bleeding or thromboembolism during PVI and/or three months of follow up	Up to three months after PVI	Any bleeding or thromboembolism observed during the PVI procedure and/or during 3 months of follow-up are registered. Also, if any procedure related complication was worsened by treatment with NOAC was registered.