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Pulmonary Vein Ablation of Atrial Fibrillation Using Magnetic Navigation: Single Ring Versus Circumferential Techniques

NCT ID: NCT01583075

Last Updated: 2012-04-24

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Brief Summary

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The single-ring ablation method aims for isolation of the posterior LA wall including the pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.

Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided single-ring ablation method as compared to standard RMN-guided circumferential PVA.

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Detailed Description

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Conditions

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Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Circumferential ablation

Group Type OTHER

Circumferential pulmonary vein ablation

Intervention Type PROCEDURE

Circumferential pulmonary vein ablation

Single ring ablation

Group Type EXPERIMENTAL

single ring pulmonary vein ablation

Intervention Type PROCEDURE

single ring pulmonary vein ablation

Interventions

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Circumferential pulmonary vein ablation

Circumferential pulmonary vein ablation

Intervention Type PROCEDURE

single ring pulmonary vein ablation

single ring pulmonary vein ablation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* drug refractory AF patients undergoing PVA

Exclusion Criteria

* drug refractory AF patients undergoing repeat PVA
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stereotaxis

INDUSTRY

Sponsor Role collaborator

University Medical Center Goettingen

OTHER

Sponsor Role lead

Responsible Party

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Markus Zabel

Prof. Dr. Markus Zabel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Zabel, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Electrophysiology, University Medical Center Goettingen

Locations

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UMC Göttingen

Göttingen, Lower Saxony, Germany

Site Status

Countries

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Germany

References

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Thomas SP, Lim TW, McCall R, Seow SC, Ross DL. Electrical isolation of the posterior left atrial wall and pulmonary veins for atrial fibrillation: feasibility of and rationale for a single-ring approach. Heart Rhythm. 2007 Jun;4(6):722-30. doi: 10.1016/j.hrthm.2007.01.034. Epub 2007 Feb 9.

Reference Type BACKGROUND
PMID: 17556191 (View on PubMed)

Other Identifiers

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STXS 10-005

Identifier Type: -

Identifier Source: org_study_id

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