Safe Use of New Oral Anticoagulants in Ablation for Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Symptomatic atrial fibrillation despite pharmacological treatment.

Exclusion criteria

None

Treatment and study plan

Pulmonary venous ostia isolation

Procedure

Percutaneous, catheterbased, radiofrequency ablation with left atrial access via atrial septal puncture. Helped by 3D-imaging system (Carto(tm)) and electrical signal guidance the PV ostia together with neighbouring atrial tissue is electrically isolated from the rest of the left atrium.

Other names: catheter ablation, PVI

Primary outcomes

Number of participants with bleeding or thromboembolism during PVI and/or three months of follow up

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Private Hospital Heart Center Varde

Other

Registry information

Official study title

Safe Use of New Oral Anticoagulants in Patients Treated by Catheter Ablation for Atrial Fibrillation

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Oct 6, 2015
Registry last updated: Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed