An interventional study of Adenosine test and Termination of AF in Paroxysmal Atrial Fibrillation, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-12.
Sponsored by Johannes Gutenberg University Mainz · Not applicable, Interventional, and Treatment
This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 150 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Adenosine testing after PVI and elimination of dormant conduction
Procedure: Adenosine test
Termination of atrial fibrillation by catheter ablation
Procedure: Termination of AF
Testing dormant conduction after PVI
Testing AF iducibility and ermination of
Arrhythmia-free survival
arrhythmia-free outcome during 1 year after the procedure
Time frame: 1 year
Recurrence if PV conduction after ablation in PVs with abolished dormant conduction
PV conduction recurrences after elimination of dormant conduction. This endpoint will be evaluated during repeat procedures for recurrences of atrial fibrillation or atrial tachycardia.
Time frame: 1 year
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Johannes Gutenberg University Mainz