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Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation (CPVA-PAF)

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ClinicalTrials.gov Identifier: NCT00556595
Recruitment Status : Unknown
Verified November 2007 by University Hospital, Bonn.
Recruitment status was:  Not yet recruiting
First Posted : November 12, 2007
Last Update Posted : November 12, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Procedure: primary electrophysiological approach Procedure: primary anatomical approach

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach
Study Start Date : November 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
primary electrophysiological approach
Procedure: primary electrophysiological approach
primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice
Active Comparator: 2
primary anatomical approach
Procedure: primary anatomical approach
primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps


Outcome Measures

Primary Outcome Measures :
  1. Freedom from atrial tachyarrhythmias at 6-months follow-up [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications) [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • paroxysmal atrial fibrillation
  • age over 18 years

Exclusion Criteria:

  • persistent atrial fibrillation
  • reversible cause of atrial fibrillation
  • inability to comply with follow-up
Contacts and Locations

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): NCT00556595


Contacts
Contact: Lars M Lickfett, MD *49-228-287-16670 lars.lickfett@ukb.uni-bonn.de

Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Lars M Lickfett, MD University Hospital Bonn, Department of Cardiology
More Information