Arrhythmias, CardiacMAGiC-FESTPMCFNCT06019845
The MAGiC™ Cardiac Ablation European Study
A study testing MAGiC™ in people with Arrhythmias, Cardiac, run by Stereotaxis at 4 sites in 4 countries.
Trial 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. The purpose of MAGiC-FEST PMCF Study is to collect safety and performance data with MAGiC to meet ongoing regulatory obligations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- MAGiC™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 2 Jan 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet, University of Copenhagen
Copenhagen
Aslaug Karlsdóttir, aslaug.thora.karlsdottir@regionh.dk
Lærke Bjerregaard Heidum, laerke.bjerregaard.heidum@regionh.dk
Lithuania1 site, 1 recruiting
- Recruiting
Vilniaus universiteto ligoninė Santaros klinikos
Vilnius
Kridtina Ščerbakovaitė, Kristina.Scerbakovaite@santa.lt
Jūratė Barysienė, Jurate.Barysiene@santa.lt
Netherlands1 site, 1 recruiting
- Not yet recruiting
Erasmus Medical Center
Rotterdam, 3015 GD
Elco van der Heide, 31630605231, e.vanderheide@erasmusmc.nl
Astrid Coenen-Vrijhoeven, RN, 31614633780, j.coenen-vrijhoeven@erasmusmc.nl
Poland1 site, 1 recruiting
- Not yet recruiting
National Institute of Cardiology
Warsaw, 04-628
Kinga Krajenska Piestrzynska, BS, +68699355636, kkrajenska@ikard.pl
Ewa Swierzynska, MSc, PhD, +68507609972, eswierzynska@ikard.pl
About this study
Official title: The MAGiC™ Cardiac Ablation Feasibility Study / Pomt Market Clinical Follow-Up
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.
Read the detailed description
The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. Now that MAGiC obtained European approval, the study has been amended and expanded to collect Post-Market Clinical Follow-up data.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- MAGiC™
- Keywords
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia, Supraventricular Tachycardia, Ablation, Premature Ventricular Contractions
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Tachycardia, Ventricular, Tachycardia, Supraventricular, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGiC™Device
Robotic magnetic radiofrequency (RF) ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Magnetic Interventional Ablation Catheter (MAGiC™) Receives: Device: MAGiC™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Performance
The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.
Measured: hospital discharge - up to 7 days post procedure
Acute Safety
Freedom from major adverse events (MAE) related to MAGiC.
Measured: hospital discharge - up to 7 days post procedure
Secondary outcomes (3)
Chronic Success
Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.
Measured: 3 months, 6 months, 12 months
Safety Events
Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.
Measured: 3 months, 6 months, 12 months
Onset of Procedure-related New Arrhythmia
Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.
Measured: 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start2 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Osypka AG
- Responsible party
- Sponsor
- Investigators
- Betsy Lowry, Study director, Stereotaxis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019845
- Sponsor's protocol ID
- MFEAS-001
- Other IDs
- CIV-23-10-044301
- Acronym
- MAGiC-FESTPMCF
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MAGiC™ Cardiac Ablation Feasibility Study / Pomt Market Clinical Follow-Up
- ClinicalTrials.gov ID
- NCT06019845
- Acronym / sponsor ID
- MAGiC-FESTPMCF / MFEAS-001
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia, Supraventricular Tachycardia, Ablation, Premature Ventricular Contractions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Collaborators
- Osypka AG
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. Now that MAGiC obtained European approval, the study has been amended and expanded to collect Post-Market Clinical Follow-up data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: MAGiC™Magnetic Interventional Ablation Catheter (MAGiC™) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAGiC™Robotic magnetic radiofrequency (RF) ablation catheter | Device | Treatment |
Primary outcome
Acute Performance
Time frame: hospital discharge - up to 7 days post procedure
The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.
Acute Safety
Time frame: hospital discharge - up to 7 days post procedure
Freedom from major adverse events (MAE) related to MAGiC.
3 secondary outcomes
Chronic Success
Time frame: 3 months, 6 months, 12 months
Safety Events
Time frame: 3 months, 6 months, 12 months
Onset of Procedure-related New Arrhythmia
Time frame: 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Betsy Lowry study director
Stereotaxis
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAGiC™ in people with Arrhythmias, Cardiac, run by Stereotaxis at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Lithuania, Netherlands, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betsy Lowry (9737236613, betsy.lowry@stereotaxis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Performance (time frame: hospital discharge - up to 7 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.