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OpenTrials
Completed

NCT Number: NCT00560872

Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

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.

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet

Göttingen, 37075, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

remote magnetic catheter navigation

Device

use of the Stereotaxis system

cavotricuspid isthmus ablation

Procedure

conventional (manual) approach

Primary outcomes

  1. ablation duration and fluoroscopy time

    Time frame: 3 months

Secondary outcomes

  1. total procedure duration, success, ablation characteristics, flutter recurrence, complications

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital Goettingen

Other

Collaborators

  • Stereotaxis

Registry information

Official study title

Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 20, 2007
Registry last updated
Dec 23, 2009

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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