Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation

Paroxysmal Atrial Fibrillation Clinical Trial

— CPVA-PAF  

Official title:

Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00556595
• Other study ID #: CPVA-PAF
• Secondary ID: IRB 160/07
• Status: Not yet recruiting
• Phase: N/A
• First received: November 9, 2007
• Last updated: November 9, 2007
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2007
• Source: University Hospital, Bonn
• Contact: Lars M Lickfett, MD
• Phone: *49-228-287-16670
• Email: lars.lickfett[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• primary electrophysiological approach
primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice
• primary anatomical approach
primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

References & Publications (3)

Arentz T, Weber R, Bürkle 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. Epub 2007 Jun 11. — View Citation

Karch MR, Zrenner B, Deisenhofer I, Schreieck J, Ndrepepa G, Dong J, Lamprecht K, Barthel P, Luciani E, Schömig 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. Epub 2005 May 31. — View 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. Epub 2003 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial tachyarrhythmias at 6-months follow-up		6 months
Secondary	Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)		6 months