Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rigshospitalet University of Copenhagen
Coordinator of this site? Confirm its status
CopenhagenDenmarkRecruiting
Vilniaus universiteto ligoninė Santaros klinikos
Coordinator of this site? Confirm its status
VilniusLithuaniaRecruiting
Erasmus Medical Center
Coordinator of this site? Confirm its status
RotterdamNetherlandsNot yet recruiting
National Institute of Cardiology
Coordinator of this site? Confirm its status
WarsawPolandNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.