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Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560872
First Posted: November 20, 2007
Last Update Posted: December 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stereotaxis
Information provided by:
University Hospital Goettingen
  Purpose
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 Intervention
Atrial Flutter Device: remote magnetic catheter navigation Procedure: cavotricuspid isthmus ablation

Study Type: Interventional
Study Design: 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

Further study details as provided by University Hospital Goettingen:

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

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

Estimated Enrollment: 100
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: November 19, 2007
First Posted: November 20, 2007
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