Actively Recruiting
The MAGiC™ Cardiac Ablation European Study
Led by Stereotaxis · Updated on 2026-05-04
150
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Stereotaxis
Lead Sponsor
O
Osypka AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The MAGiC™ Cardiac Ablation European Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, electrocardiographically documented within 12 months prior 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
You will not qualify if you...
- 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
- 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 adequate anticoagulation
- Acute myocardial infarct within the previous 6 weeks
- Recent cardiac surgery within the previous 8 weeks
- Unstable angina at the time of enrollment
- History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days
- Previous cardiac ablation within the previous 30 days
- EP ablation within the previous 6 weeks
- Life expectancy less than 12 months per the physician opinion
- Currently or in the 30 days prior to consent, participation in an interventional clinical trial
- Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study
- Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark
Actively Recruiting
2
Vilniaus universiteto ligoninė Santaros klinikos
Vilnius, Lithuania
Actively Recruiting
3
Erasmus Medical Center
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
4
National Institute of Cardiology
Warsaw, Poland, 04-628
Not Yet Recruiting
Research Team
B
Betsy Lowry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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