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Trial record 59 of 1217 for:    adenosine
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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
Sponsor:
Information provided by (Responsible Party):
Thomas Rostock, Johannes Gutenberg University Mainz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Procedure: Adenosine test Procedure: Termination of AF Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Arrhythmia-free survival [ Time Frame: 1 year ]
    arrhythmia-free outcome during 1 year after the procedure


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • persistent AF
  • previous cardioversion
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
University Hospital Mainz, Department of Medicine II
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Thomas Rostock, MD University Hospital Mainz, Dept. of Cardiology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Rostock, Thomas Rostock, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02238392    
Other Study ID Numbers: 1/2014
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by Thomas Rostock, Johannes Gutenberg University Mainz:
paroxysmal atrial fibrillation
pulmonary vein isolation
adenosine
AF terminatin
Additional relevant MeSH terms:
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Adenosine
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action