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OpenTrials
Completed

NCT Number: NCT01091597

Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.

Exclusion criteria

  • Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation

Treatment and study plan

usual PV ablation

Procedure

usual PV ablation, per above

Box isolation of pulmonary veins

Procedure

as above

Primary outcomes

  1. freedom from atrial fibrillation

    Time frame: 3 months following ablation

Secondary outcomes

  1. safety of Box isolation

    Time frame: 3 months following procedure

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 24, 2010
Registry last updated
Mar 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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