MAGiC Cardiac Ablation for Arrhythmias in Europe
The MAGiC™ Cardiac Ablation Feasibility Study / Pomt Market Clinical Follow-Up
This study is testing a new cardiac ablation system called MAGiC to see if it is safe and effective for adults with heart rhythm problems like atrial fibrillation and ventricular tachycardia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stereotaxis Industry-sponsored |
| Locations | 4 sites (Copenhagen and 3 other locations) |
| Trial ID | NCT06019845 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to collect safety and performance data on the MAGiC cardiac ablation system to support its marketing approval in Europe. The study will involve adult patients eligible for ablation procedures for various arrhythmias, including atrial fibrillation and ventricular tachycardia. Participants will undergo the MAGiC procedure and will be monitored for up to 12 months to assess outcomes and safety. Following European approval, the study will be expanded to include post-market clinical follow-up data.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with documented episodes of tachyarrhythmia eligible for ablation procedures.
Not a fit: Patients who cannot be safely exposed to magnetic fields or have certain implanted devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from arrhythmias.
How similar studies have performed: Other studies have shown promise with similar cardiac ablation technologies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 \<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 (limitation on survival). * Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation.
Where this trial is running
Copenhagen and 3 other locations
- Rigshospitalet, University of Copenhagen — Copenhagen, Denmark (Recruiting)
- Vilniaus universiteto ligoninė Santaros klinikos — Vilnius, Lithuania (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Not_yet_recruiting)
- National Institute of Cardiology — Warsaw, Poland (Not_yet_recruiting)
Study contacts
- Study coordinator: Betsy Lowry
- Email: betsy.lowry@stereotaxis.com
- Phone: 9737236613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.