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Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

Primary Purpose

Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
remote magnetic catheter navigation
cavotricuspid isthmus ablation
Sponsored by
University Hospital Goettingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring atrial flutter, ablation, navigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

1

2

Arm Description

conventional ablation with manual catheter navigation

ablation with remote magnetic catheter navigation

Outcomes

Primary Outcome Measures

ablation duration and fluoroscopy time

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2007
Last Updated
December 22, 2009
Sponsor
University Hospital Goettingen
Collaborators
Stereotaxis
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1. Study Identification

Unique Protocol Identification Number
NCT00560872
Brief Title
Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation
Official Title
Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Goettingen
Collaborators
Stereotaxis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
atrial flutter, ablation, navigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
conventional ablation with manual catheter navigation
Arm Title
2
Arm Type
Active Comparator
Arm Description
ablation with remote magnetic catheter navigation
Intervention Type
Device
Intervention Name(s)
remote magnetic catheter navigation
Intervention Description
use of the Stereotaxis system
Intervention Type
Procedure
Intervention Name(s)
cavotricuspid isthmus ablation
Intervention Description
conventional (manual) approach
Primary Outcome Measure Information:
Title
ablation duration and fluoroscopy time
Time Frame
3 months
Secondary Outcome Measure Information:
Title
total procedure duration, success, ablation characteristics, flutter recurrence, complications
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Vollmann, PD Dr. med.
Organizational Affiliation
Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet
City
Goettingen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20009074
Citation
Vollmann D, Luthje L, Seegers J, Hasenfuss G, Zabel M. Remote magnetic catheter navigation for cavotricuspid isthmus ablation in patients with common-type atrial flutter. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):603-10. doi: 10.1161/CIRCEP.109.884411.
Results Reference
derived

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Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

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