RecruitingNot ApplicableNCT06019845
The MAGiC™ Cardiac Ablation European Study
The MAGiC™ Cardiac Ablation Feasibility Study
Sponsor
Stereotaxis
Enrollment
150 participants
Start Date
Jan 2, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This European study evaluates the safety and effectiveness of the MAGiC cardiac ablation system — a magnetically-guided catheter used to treat abnormal heart rhythms (arrhythmias) — in real-world clinical practice.
**You may be eligible if...**
- You are 18 or older
- You have an abnormal heart rhythm (atrial or ventricular) that qualifies for ablation per European guidelines, with at least one documented episode in the past 6 months
- You can safely be exposed to magnetic fields
- You are willing and able to attend follow-up visits for up to 12 months
**You may NOT be eligible if...**
- You have a device that is unsafe in magnetic fields (like certain pacemakers) that cannot be removed
- You weigh more than 200 kg
- You are pregnant or unwilling to take a pregnancy test
- You have a blood clot in the heart, a prosthetic heart valve requiring crossing, or recent heart attack (within 30 days) or cardiac surgery (within 60 days)
- You are hemodynamically unstable
- For atrial fibrillation: you have persistent AF lasting more than 7 days
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
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Interventions
DEVICEMAGiC™
Robotic magnetic radiofrequency (RF) ablation catheter
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06019845
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