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Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

This study has been completed.
Sponsor:
Collaborator:
Stereotaxis
Information provided by:
University Hospital Goettingen
ClinicalTrials.gov Identifier:
NCT00560872
First received: November 19, 2007
Last updated: December 22, 2009
Last verified: December 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total procedure duration, success, ablation characteristics, flutter recurrence, complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital Goettingen

Additional 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
Study First Received: November 19, 2007
Last Updated: December 22, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Goettingen:
atrial flutter
ablation
navigation

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

ClinicalTrials.gov processed this record on June 13, 2013