Adenosine vs AF Termination for Paroxysmal AF Ablation
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|ClinicalTrials.gov Identifier: NCT02238392|
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Procedure: Adenosine test Procedure: Termination of AF||Not Applicable|
Despite intensive efforts to increase single procedure success rates of pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has not raised beyond 80%. This prospective, randomized study investigates the efficacy of two different procedural endpoints in terms of single-procedure arrhythmia-free outcome.
A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be randomized to two different treatment arms. In group-A patients, PVI will be performed with the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation will be continued by targeting extra-PV AF sources with the desired endpoint of termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to adenosine administration in the attempt to reveal and ablate dormant conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: Group A
Adenosine testing after PVI and elimination of dormant conduction
Procedure: Adenosine test
Testing dormant conduction after PVI
Active Comparator: Group B - Termination of AF
Termination of atrial fibrillation by catheter ablation
Procedure: Termination of AF
Testing AF iducibility and ermination of
- Arrhythmia-free survival [ Time Frame: 1 year ]arrhythmia-free outcome during 1 year after the procedure
- Recurrence if PV conduction after ablation in PVs with abolished dormant conduction [ Time Frame: 1 year ]PV conduction recurrences after elimination of dormant conduction. This endpoint will be evaluated during repeat procedures for recurrences of atrial fibrillation or atrial tachycardia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238392
|University Hospital Mainz, Department of Medicine II|
|Mainz, Germany, 55131|
|Principal Investigator:||Thomas Rostock, MD||University Hospital Mainz, Dept. of Cardiology|