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A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation

NCT ID: NCT00192972

Last Updated: 2005-12-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-06-30

Brief Summary

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Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.

In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.

Detailed Description

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Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.

In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Each patient was allowed a maximum of two ablation procedures. Holter monitoring for 14-days periods will be performed at 3 months after ablation. The patiens are seen at out-patient visits at 1, 3, 6, 9, and 12 months after the ablation procedure.

Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.

Secondary endpoints were:

* safety
* resumption of LA-PV conduction
* alterations in neurohormones
* socio-economics aspects(cost effectiveness)
* changes in inflammatory markers
* quality of life
* alterations in signal averaged P wawe signals
* evaluation of the predictive value of these variables to predict recurrence of AF

Conditions

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Atrial Fibrillation Arrhythmia

Keywords

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Catheter ablation Atrial fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Catheter ablation (pulmonary vein isolation)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* symptomatic paroxysmal or persistent AF for more than 6 months, with at least 3 episodes in 3 months and with insufficient effect of at least 2 pharmacological regimens

Exclusion Criteria

* congenital heart disease
* age under 18 years
* significant valve disease
* left atrial size \> 55 mm
* prior ablation for AF
* Severe heart failure (LVEF \< 20 % and/or NYHA class IV)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Biosense Webster, Inc.

INDUSTRY

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Guidant Corporation

INDUSTRY

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Brian Nilsson, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Xu Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Righospitalet, Copenhagen, Denmark

Steen M Pehrson, MD

Role: PRINCIPAL_INVESTIGATOR

Righospitalet, Copenhagen, Denmark

Lars Køber, MD

Role: PRINCIPAL_INVESTIGATOR

Righospitalet, Copenhagen, Denmark

Jørgen Hilden, MD

Role: PRINCIPAL_INVESTIGATOR

Department of biostatistics, University of Copenhagen

Jesper H Svendsen, MD

Role: PRINCIPAL_INVESTIGATOR

Righospitalet, Copenhagen, Denmark

Locations

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Righospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Oral H, Chugh A, Lemola K, Cheung P, Hall B, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Morady F. Noninducibility of atrial fibrillation as an end point of left atrial circumferential ablation for paroxysmal atrial fibrillation: a randomized study. Circulation. 2004 Nov 2;110(18):2797-801. doi: 10.1161/01.CIR.0000146786.87037.26. Epub 2004 Oct 25.

Reference Type BACKGROUND
PMID: 15505091 (View on PubMed)

Other Identifiers

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LASCAR

Identifier Type: -

Identifier Source: org_study_id