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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University Hospital, Bonn.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00556595
First received: November 9, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention
Paroxysmal Atrial Fibrillation
Procedure: primary electrophysiological approach
Procedure: primary anatomical approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

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

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

Estimated Enrollment: 200
Study Start Date: November 2007
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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