ADenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination: the ADVICE Trial (ADVICE)
Paroxysmal Atrial Fibrillation, Pulmonary Vein Isolation, Dormant Pulmonary Vein Conduction
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring catheter ablation, atrial fibrillation, adenosine
Eligibility Criteria
Inclusion Criteria:
- Age more than 18 years
- Paroxysmal AF for at least 6 months with at least 3 symptomatic episodes (using patient history) during the previous 6 months
- Patients must be felt to be candidates for AF ablation based on AF that is symptomatic and refractory or intolerant to at least one class 1 or 3 antiarrhythmic agent.
- Documentation of at least one episode of AF on 12 lead ECG, TTM or Holter monitor within 12 months of randomization in the trial
- Patients must be on continuous anticoagulation with warfarin (INR 2-3) or fractionated subcutaneous heparin for >4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesophageal echocardiogram to exclude left atrial thrombus.
- Patients must provide written informed consent to participate in the clinical trial.
Exclusion Criteria:
- Contraindications to oral anticoagulants
- History of any previous ablation or surgical maze for AF
- Intracardiac thrombus
- AF due to reversible cause
- Patients with left atrial size > 55mm or significant mitral valve disease (moderate or severe mitral stenosis or regurgitation)
- Pregnancy
- Asthma, history of bronchospasm or known adverse reaction to adenosine
Sites / Locations
- Royal Perth Hospital
- KH d. Elisabethinen Linz GmbH
- Cliniques universitaires Saint-Luc
- Foothills Medical Center
- Royal Jubilee Hospital
- QE II Health Sciences Center
- McMaster University and Hamilton Health Sciences
- London Health Science Centers
- Southlake Regional Health Center
- Ottawa Heart Institute
- Montreal General Hospital
- Montreal Heart Institute
- Centre hospitalier universitaire de Sherbrooke
- Institut universitaire de cardiologie et de pneumologie de Québec
- Hôpital Cardiologique du Haut-Lévêque
- University Heart Center
- Deutsches Herzzentrum Muenchen
- Herz-Zentrum Bad Krozingen
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Dormant PV conduction
No dormant PV conduction
After PVI, dormant conduction will be evaluated using intravenous adenosine. If dormant conduction is present, the patients will be randomized to two parallel groups: Group 1: No additional ablation Group 2: Additional ablation until elimination of dormant conduction.
If no dormant conduction is documented, patients will be selected in a random fashion to be included in a registry (follow-up as planned for group 1 and 2 above). The registry group will allow for further assessment of the role of dormant conduction as a predictor of AF recurrence by comparing the success rate after ablation in patients without dormant conduction with those of Group 1 and 2.