Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2012-01-31
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Adenosine testing after PVI and elimination of dormant conduction
Adenosine test
Testing dormant conduction after PVI
Group B - Termination of AF
Termination of atrial fibrillation by catheter ablation
Termination of AF
Testing AF iducibility and ermination of
Interventions
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Adenosine test
Testing dormant conduction after PVI
Termination of AF
Testing AF iducibility and ermination of
Eligibility Criteria
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Inclusion Criteria
* de-novo AF ablation
* age \> 18 years
Exclusion Criteria
* previous cardioversion
18 Years
ALL
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Thomas Rostock
Thomas Rostock, MD
Principal Investigators
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Thomas Rostock, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Mainz, Dept. of Cardiology
Locations
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University Hospital Mainz, Department of Medicine II
Mainz, , Germany
Countries
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References
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Theis C, Konrad T, Mollnau H, Sonnenschein S, Kampfner D, Potstawa M, Ocete BQ, Bock K, Himmrich E, Munzel T, Rostock T. Arrhythmia Termination Versus Elimination of Dormant Pulmonary Vein Conduction as a Procedural End Point of Catheter Ablation for Paroxysmal Atrial Fibrillation: A Prospective Randomized Trial. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1080-7. doi: 10.1161/CIRCEP.115.002786. Epub 2015 Aug 21.
Other Identifiers
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1/2014
Identifier Type: -
Identifier Source: org_study_id
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