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Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

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ClinicalTrials.gov Identifier: NCT00560872
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : December 23, 2009
Sponsor:
Collaborator:
Stereotaxis
Information provided by:
University Hospital Goettingen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Flutter Device: remote magnetic catheter navigation Procedure: cavotricuspid isthmus ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter
Study Start Date : August 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

Arm Intervention/treatment
1
conventional ablation with manual catheter navigation
Procedure: cavotricuspid isthmus ablation
conventional (manual) approach
Active Comparator: 2
ablation with remote magnetic catheter navigation
Device: remote magnetic catheter navigation
use of the Stereotaxis system



Primary Outcome Measures :
  1. ablation duration and fluoroscopy time [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. total procedure duration, success, ablation characteristics, flutter recurrence, complications [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560872


Locations
Germany
Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet
Goettingen, Germany, 37075
Sponsors and Collaborators
University Hospital Goettingen
Stereotaxis
Investigators
Principal Investigator: Dirk Vollmann, PD Dr. med. Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. med. Dirk Vollmann, Universitaetsmedizin Goettingen, Germany
ClinicalTrials.gov Identifier: NCT00560872     History of Changes
Other Study ID Numbers: MN-07-022-GOE
Stereotaxis#07-022
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by University Hospital Goettingen:
atrial flutter
ablation
navigation

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes