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Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

NCT ID: NCT00560872

Last Updated: 2009-12-23

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

2007-08-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.

Detailed Description

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Conditions

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Atrial Flutter

Keywords

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atrial flutter ablation navigation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

conventional ablation with manual catheter navigation

Group Type OTHER

cavotricuspid isthmus ablation

Intervention Type PROCEDURE

conventional (manual) approach

2

ablation with remote magnetic catheter navigation

Group Type ACTIVE_COMPARATOR

remote magnetic catheter navigation

Intervention Type DEVICE

use of the Stereotaxis system

Interventions

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remote magnetic catheter navigation

use of the Stereotaxis system

Intervention Type DEVICE

cavotricuspid isthmus ablation

conventional (manual) approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ECG documentation of at least 1 episode of typical atrial flutter

Exclusion Criteria

* Prior right atrial ablation
* Ferromagnetic implants that may interfere with the magnetic navigation system
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stereotaxis

INDUSTRY

Sponsor Role collaborator

University Hospital Goettingen

OTHER

Sponsor Role lead

Responsible Party

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Universitaetsmedizin Goettingen, Germany

Principal Investigators

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Dirk Vollmann, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen

Locations

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Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet

Göttingen, , Germany

Site Status

Countries

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Germany

References

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Vollmann D, Luthje L, Seegers J, Hasenfuss G, Zabel M. Remote magnetic catheter navigation for cavotricuspid isthmus ablation in patients with common-type atrial flutter. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):603-10. doi: 10.1161/CIRCEP.109.884411.

Reference Type DERIVED
PMID: 20009074 (View on PubMed)

Other Identifiers

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Stereotaxis#07-022

Identifier Type: -

Identifier Source: secondary_id

MN-07-022-GOE

Identifier Type: -

Identifier Source: org_study_id