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Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation

NCT ID: NCT00556595

Last Updated: 2007-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Paroxysmal Atrial Fibrillation

Keywords

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atrial fibrillation paroxysmal symptomatic drug-refractory

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

primary electrophysiological approach

Group Type EXPERIMENTAL

primary electrophysiological approach

Intervention Type PROCEDURE

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

2

primary anatomical approach

Group Type ACTIVE_COMPARATOR

primary anatomical approach

Intervention Type PROCEDURE

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

Interventions

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primary electrophysiological approach

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

Intervention Type PROCEDURE

primary anatomical approach

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Principal Investigators

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Lars M Lickfett, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bonn, Department of Cardiology

Central Contacts

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Lars M Lickfett, MD

Role: CONTACT

Phone: *49-228-287-16670

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 14557355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17562956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15927974 (View on PubMed)

Other Identifiers

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IRB 160/07

Identifier Type: -

Identifier Source: secondary_id

CPVA-PAF

Identifier Type: -

Identifier Source: org_study_id