Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

University Hospital Goettingen

Status: Completed

Conditions: Atrial Flutter

Treatments: Device: remote magnetic catheter navigation; Procedure: cavotricuspid isthmus ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00560872

MN-07-022-GOE

Stereotaxis#07-022

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Other group

Description:

conventional ablation with manual catheter navigation

Treatment:

Procedure: cavotricuspid isthmus ablation

2

Active Comparator group

Description:

ablation with remote magnetic catheter navigation

Treatment:

Device: remote magnetic catheter navigation