Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560872

Enrollment

100

Registered

2007-11-20

Start date

2007-08-31

Completion date

2009-06-30

Last updated

2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Flutter

Keywords

atrial flutter, ablation, navigation

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.

Interventions

DEVICEremote magnetic catheter navigation

use of the Stereotaxis system

PROCEDUREcavotricuspid isthmus ablation

conventional (manual) approach

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
ablation duration and fluoroscopy time	3 months

Secondary

Measure	Time frame
total procedure duration, success, ablation characteristics, flutter recurrence, complications	6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026