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
This trial does not accept healthy volunteersQualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
MAGiC™
DeviceRobotic magnetic radiofrequency (RF) ablation catheter
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute Performance
The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.
Time frame
hospital discharge - up to 7 days post procedure2
Acute Safety
Freedom from major adverse events (MAE) related to MAGiC.
Time frame
hospital discharge - up to 7 days post procedureSecondary outcomes
1
Chronic Success
Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.
Time frame
3 months, 6 months, 12 months2
Safety Events
Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.
Time frame
3 months, 6 months, 12 months3
Onset of Procedure-related New Arrhythmia
Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.
Time frame
3 months, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stereotaxis
Lead sponsor
Osypka AG
Collaborator
Source ClinicalTrials.gov