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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:

U.S. FDA Resources

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
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

Publications:

ClinicalTrials.gov Identifier: NCT00556595     History of Changes
Other Study ID Numbers: CPVA-PAF, IRB 160/07
Study First Received: November 9, 2007
Last Updated: November 9, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Bonn:
atrial fibrillation
paroxysmal
symptomatic
drug-refractory

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013