The MAGiC™ Cardiac Ablation European Study

ConditionArrhythmias, Cardiac

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorStereotaxis

About this trial

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.

The purpose of MAGiC-FEST PMCF Study is to collect safety and performance data with MAGiC to meet ongoing regulatory obligations.

Eligibility criteria

Qualifiers

Adult (aged 18 or older at time of consent);

Eligible for ablation procedures of an atrial or ventricular arrhythmia per European Heart Rhythm Association (EHRA) guidelines, lctrocardiographically documented within 12 months [rior to enrollment;

Able to be safely exposed to magnetic fields;

Willing and capable to attend scheduled follow up visits at the study site for the study duration (up to 12 months)

Disqualifiers

Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging Unsafe device (implanted device or device that cannot be safely removed for the procedure)

Unable to remain comfortable or hemodynamically stable in the supine position for an extended period of time

Weight exceeding 200 kg (the weight limit of the table)

Women of childbearing age who are pregnant or who plan to become pregnant within the course of their participation in the study. Must have a negative pregnancy test.