Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

This study is currently recruiting participants.

Verified by University Hospital Goettingen, November 2007

Sponsors and Collaborators:	University Hospital Goettingen Stereotaxis
Information provided by:	University Hospital Goettingen
ClinicalTrials.gov Identifier:	NCT00560872

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

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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: procedural ]

Secondary Outcome Measures:

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

Estimated Enrollment:	150
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2009

Arms	Assigned Interventions
1 conventional ablation with manual catheter navigation	Procedure: cavotricuspid isthmus ablation conventional (manual) approach
2: Active Comparator 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

Contacts

Contact: Dirk Vollmann, Dr. med.	+49(0)55139 ext 12970	dirkvollmann2000@aol.com
Contact: Markus Zabel, Prof. Dr.	+49(0)55139 ext 10266	markus.zabel@med.uni-goettingen.de

Locations

Germany
Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet	Recruiting
Goettingen, Germany, 37075
Principal Investigator: Dirk Vollmann, Dr. med.
Sub-Investigator: Markus Zabel, Prof. Dr.
Sub-Investigator: Lars Luethje, Dr. med.

Sponsors and Collaborators

University Hospital Goettingen

Stereotaxis

Investigators

Principal Investigator:

Dirk Vollmann, Dr. med.

Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen

More Information

Study ID Numbers:	MN-07-022-GOE, Stereotaxis#07-022
Study First Received:	November 19, 2007
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00560872
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Goettingen:

atrial flutter
ablation
navigation

Study placed in the following topic categories:

Heart Diseases
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009