NCT06019845Recruiting
The MAGiC™ Cardiac Ablation European Study
The MAGiC™ Cardiac Ablation Feasibility Study / Pomt Market Clinical Follow-Up
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 23 Aug 2023
- Start date
- Jan 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Stereotaxis
- Diseases
- Atrial fibrillation
- NCT number
- NCT06019845
What you commit to
- Study type: Interventional
- Planned participants: 150
- From Jan 2024 to the primary completion date, Dec 2027
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of intracardiac thrombus within 12 weeks prior to enrollment
- Acute myocardial infarct (within the previous 6 weeks)
- Recent cardiac surgery (within the previous 8 weeks)
- 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.
- Currently or in the 30 days prior to consent, participation in an interventional clinical trial
Other illness
- 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
- Unstable angina at the time of enrollment
- Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation.
Age
- 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.
Other
- 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)
- Where MAGiC would need to cross a prosthetic valve
- Use of MAGiC in the coronary arteries
- Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- Life expectancy \<12 months per the physician opinion.
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet University of Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Vilniaus universiteto ligoninė Santaros klinikos Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| National Institute of Cardiology Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.