Back to resultsPrimary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation (CPVA-PAF)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
primary electrophysiological approach
primary anatomical approach
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, paroxysmal, symptomatic, drug-refractory
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
primary electrophysiological approach
primary anatomical approach
Outcomes
Primary Outcome Measures
Freedom from atrial tachyarrhythmias at 6-months follow-up
Secondary Outcome Measures
Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)
Full Information
NCT ID
NCT00556595
First Posted
November 9, 2007
Last Updated
November 9, 2007
Sponsor
University Hospital, Bonn
1. Study Identification
Unique Protocol Identification Number
NCT00556595
Brief Title
Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation
Acronym
CPVA-PAF
Official Title
Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bonn
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
atrial fibrillation, paroxysmal, symptomatic, drug-refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
primary electrophysiological approach
Arm Title
2
Arm Type
Active Comparator
Arm Description
primary anatomical approach
Intervention Type
Procedure
Intervention Name(s)
primary electrophysiological approach
Intervention Description
primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice
Intervention Type
Procedure
Intervention Name(s)
primary anatomical approach
Intervention Description
primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps
Primary Outcome Measure Information:
Title
Freedom from atrial tachyarrhythmias at 6-months follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars M Lickfett, MD
Phone
*49-228-287-16670
Email
lars.lickfett@ukb.uni-bonn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars M Lickfett, MD
Organizational Affiliation
University Hospital Bonn, Department of Cardiology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
14557355
Citation
Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.
Results Reference
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PubMed Identifier
17562956
Citation
Arentz T, Weber R, Burkle G, Herrera C, Blum T, Stockinger J, Minners J, Neumann FJ, Kalusche D. Small or large isolation areas around the pulmonary veins for the treatment of atrial fibrillation? Results from a prospective randomized study. Circulation. 2007 Jun 19;115(24):3057-63. doi: 10.1161/CIRCULATIONAHA.107.690578. Epub 2007 Jun 11.
Results Reference
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PubMed Identifier
15927974
Citation
Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schomig A, Schmitt C. Freedom from atrial tachyarrhythmias after catheter ablation of atrial fibrillation: a randomized comparison between 2 current ablation strategies. Circulation. 2005 Jun 7;111(22):2875-80. doi: 10.1161/CIRCULATIONAHA.104.491530. Epub 2005 May 31.
Results Reference
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Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation
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