NCT06019845

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Dec 2028

First Submitted

Initial submission to the registry

August 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

August 23, 2023

Last Update Submit

April 28, 2026

Conditions

Arrhythmias, Cardiac

Keywords

Atrial FibrillationAtrial FlutterVentricular TachycardiaSupraventricular TachycardiaAblationPremature Ventricular Contractions

Outcome Measures

Primary Outcomes (2)

  • Acute Performance

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

    hospital discharge - up to 7 days post procedure

  • Acute Safety

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

    hospital discharge - up to 7 days post procedure

Secondary Outcomes (3)

  • Chronic Success

    3 months, 6 months, 12 months

  • Safety Events

    3 months, 6 months, 12 months

  • Onset of Procedure-related New Arrhythmia

    3 months, 6 months, 12 months

Study Arms (1)

Treatment

EXPERIMENTAL

Magnetic Interventional Ablation Catheter (MAGiC™)

Device: MAGiC™

Interventions

MAGiC™DEVICE

Robotic magnetic radiofrequency (RF) ablation catheter

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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, transient ischemic attack, systemic embolism) in the previous 30 days
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rigshospitalet, University of Copenhagen

Copenhagen, Denmark

RECRUITING

Vilniaus universiteto ligoninė Santaros klinikos

Vilnius, Lithuania

RECRUITING

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

NOT YET RECRUITING

National Institute of Cardiology

Warsaw, 04-628, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial FibrillationAtrial FlutterTachycardia, VentricularTachycardia, SupraventricularVentricular Premature Complexes

Interventions

Magic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System DiseaseCardiac Complexes, Premature

Intervention Hierarchy (Ancestors)

Spiritual TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Betsy Lowry

    Stereotaxis

    STUDY DIRECTOR

Central Study Contacts

Betsy Lowry

CONTACT

9737236613betsy.lowry@stereotaxis.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 31, 2023

Study Start

January 2, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)DK(1)NL(1)PL(1)