Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation

NCT00556595 | Unknown

• 2 other identifiers: CPVA-PAFIRB 160/07
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Paroxysmal Atrial Fibrillation

Keywords

atrial fibrillation; paroxysmal; symptomatic; drug-refractory

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial tachyarrhythmias at 6-months follow-up

  6 months

Secondary Outcomes (1)

• Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)

  6 months

Study Arms (2)

1

EXPERIMENTAL

primary electrophysiological approach

Procedure: primary electrophysiological approach

2

ACTIVE COMPARATOR

primary anatomical approach

Procedure: primary anatomical approach

Interventions

primary electrophysiological approach PROCEDURE

primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice

1

primary anatomical approach PROCEDURE

primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• paroxysmal atrial fibrillation
• age over 18 years

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Related Publications (3)

• 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.

  PMID: 14557355 BACKGROUND

• 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.

  PMID: 17562956 BACKGROUND

• 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.

  PMID: 15927974 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars M Lickfett, MD

  University Hospital Bonn, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars M Lickfett, MD

CONTACT

*49-228-287-16670; lars.lickfett@ukb.uni-bonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: November 1, 2007
• Study Completion: December 1, 2008
• Last Updated: November 12, 2007

Record last verified: 2007-11