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Adenosine vs AF Termination for Paroxysmal AF Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02238392
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Information provided by (Responsible Party):
Thomas Rostock, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date  ICMJE September 9, 2014
First Posted Date  ICMJE September 12, 2014
Last Update Posted Date September 12, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
Arrhythmia-free survival [ Time Frame: 1 year ]
arrhythmia-free outcome during 1 year after the procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Adenosine vs AF Termination for Paroxysmal AF Ablation
Official Title  ICMJE Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial
Brief Summary This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE
  • Procedure: Adenosine test
    Testing dormant conduction after PVI
  • Procedure: Termination of AF
    Testing AF iducibility and ermination of
Study Arms  ICMJE
  • Active Comparator: Group A
    Adenosine testing after PVI and elimination of dormant conduction
    Intervention: Procedure: Adenosine test
  • Active Comparator: Group B - Termination of AF
    Termination of atrial fibrillation by catheter ablation
    Intervention: Procedure: Termination of AF
Publications * Theis C, Konrad T, Mollnau H, Sonnenschein S, Kämpfner D, Potstawa M, Ocete BQ, Bock K, Himmrich E, Münzel 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2014)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with paroxysmal AF
  • de-novo AF ablation
  • age > 18 years

Exclusion Criteria:

  • persistent AF
  • previous cardioversion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02238392
Other Study ID Numbers  ICMJE 1/2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Rostock, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE Johannes Gutenberg University Mainz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Rostock, MD University Hospital Mainz, Dept. of Cardiology
PRS Account Johannes Gutenberg University Mainz
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP