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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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)
* Willing and able to provide informed consent.
Exclusion Criteria:
* 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.
* Presence of intracardiac thrombus within 12 weeks prior to enrollment
* Where MAGiC would need to cross a prosthetic valve
* Use of MAGiC in the coronary arteries
* A history of sensitivity to foreign objects or extreme allergies
* Acute illness or active systemic infection
* Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection
* Unable to receive heparin or an acceptable alternative to achieve ad…
What they're measuring
1
Acute Performance
Timeframe: hospital discharge - up to 7 days post procedure
2
Acute Safety
Timeframe: hospital discharge - up to 7 days post procedure