Taking people in LithuaniaNo phase
Tests the MAGiC device for treating heart rhythm problems
Gathers safety and performance data on the MAGiC device in adults with heart rhythm disorders.
Key facts
- Who runs it
- Stereotaxis
- Where
- Vilnius, LithuaniaSee the siteAlso in 3 other countries, 3 sites
- Trial code
- Registry title
- The MAGiC™ Cardiac Ablation European Study
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 2 Jan 2024
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional
- Treatments tested
- MAGiC™
- Record updated
- 4 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a catheter ablation for an abnormal heart rhythm. It tests a device called MAGiC.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- An abnormal heart rhythm in the upper or lower chambers of the heart, documented on an electrocardiogram within 12 months before joining. Guidelines of the European Heart Rhythm Association must support ablation.
- Earlier treatment
- No heart ablation in the previous 30 days. No electrophysiology ablation in the previous 6 weeks. No heart surgery in the previous 8 weeks.
Main reasons for not taking part
- Cannot be safely exposed to magnetic fields
- Weight over 200 kg (441 lb)
- Heart attack in the previous 6 weeks
- Blood clot inside the heart in the 12 weeks before joining
- Life expectancy under 12 months, in the doctor's opinion
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
- 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)
Where in Lithuania
Also in 3 other countries, 3 sites
- Vilniaus universiteto ligoninė Santaros klinikosVilnius, LithuaniaContact: Kridtina ŠčerbakovaitėTaking people
About the trial
What the trial wants to find out
The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.
Read full original descriptionShow less
The purpose of MAGiC-FEST PMCF Study is to collect safety and performance data with MAGiC to meet ongoing regulatory obligations.
The group in the trial
- TreatmentTreatment being tested
Magnetic Interventional Ablation Catheter (MAGiC™)
Treatment: MAGiC™
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The MAGiC™ Cardiac Ablation Feasibility Study / Pomt Market Clinical Follow-Up
- Plain-language title
- Tests the MAGiC device for treating heart rhythm problemsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 May 2026