ClinicalTrials.gg
RecruitingNCT06019845MAGiC-FESTPMCFUpdated May 4, 2026

The MAGiC™ Cardiac Ablation European Study

An interventional study of MAGiC™ in Arrhythmias, Cardiac, sponsored by Stereotaxis. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Stereotaxis · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Arrhythmias, Cardiac

Keywords

  • Atrial Fibrillation
  • Atrial Flutter
  • Ventricular Tachycardia
  • Supraventricular Tachycardia
  • Ablation
  • Premature Ventricular Contractions
03

In context

Arrhythmias, Cardiac

1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Stereotaxis is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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, , systemic embolism) in the previous 30 days
  • Previous cardiac ablation within the previous 30 days
  • EP ablation within the previous 6 weeks.
  • \<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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Treatment

    Magnetic Interventional Ablation Catheter (MAGiC™)

    Device: MAGiC™

Interventions

  • DeviceMAGiC™

    Robotic magnetic radiofrequency (RF) ablation catheter

06

What researchers measure

Primary outcomes

  1. Acute Performance

    The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.

    Time frame: hospital discharge - up to 7 days post procedure

  2. Acute Safety

    Freedom from major adverse events (MAE) related to MAGiC.

    Time frame: hospital discharge - up to 7 days post procedure

Secondary outcomes

  1. Chronic Success

    Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.

    Time frame: 3 months, 6 months, 12 months

  2. Safety Events

    Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.

    Time frame: 3 months, 6 months, 12 months

  3. Onset of Procedure-related New Arrhythmia

    Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.

    Time frame: 3 months, 6 months, 12 months

07

Study locations

2 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06019845
Lead sponsor
Stereotaxis
Collaborators
Osypka AG
Responsible party
Sponsor
First posted
Aug 31, 2023
Start date
Jan 2, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 4, 2026

Study contacts

Betsy Lowry
Contact
betsy.lowry@stereotaxis.com
9737236613
Betsy Lowry
study director · Stereotaxis

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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