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Not yet recruitingNCT07812818MAGiC-CHDUpdated Sep 10, 2026

MAGiC - Congenital Heart DIsease

An observational study in Supraventricular Tachycardia (SVT) and Congenital Heart Disease (CHD), sponsored by Stereotaxis. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Stereotaxis · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study summary

The goal of this observational study is to collect real world performance and to confirm the effectiveness and safety of the MAGiC Ablation Catheter for the treatment of supraventricular tachycardia in adult patients with congenital heart disease:

To estimate the rate of acute procedural success and to estimate the rate of chronic success through 6 months post procrdure.

Participants will be asked to have a cardiac ablation procedure and visit their doctor at 1 week, 1 month and 6 monhs post procedure.

Read the detailed description

The MAGiC-CHD Post-Approval Study is a prospective, non-randomized, multi-center, single-arm study to confirm the effectiveness and safety of the MAGiC Ablation Catheter for the treatment of supraventricular tachycardia (SVT) in adult patients with congenital heart disease (CHD) and limited vascular access or difficult access to the target cardiac chamber.

02

Conditions studied

  • Supraventricular Tachycardia (SVT)
  • Congenital Heart Disease (CHD)

Keywords

  • cardiac ablation
03

In context

Tachycardia, Supraventricular

73 studies on the registry are indexed under Tachycardia, Supraventricular; 22 are open to participants now.

This study's planned enrollment of 40 is below the median of 87 across 28 observational studies indexed under Tachycardia, Supraventricular.

Browse Tachycardia, Supraventricular 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
Sampling method
Non-probability sample

Study population

Any patients requiring an ablation procrdure for the treatment of SVT with CHD where there is limited vascular ascess or difficult to access the target cardiac chamber

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).
  • Clinically indicated for catheter ablation of a supraventricular tachycardia (macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia)
  • History of congenital heart disease with anatomic abnormalities and/or previous surgical interventions and/or previous surgical interventions that limit vascular or target chamber access by conventional manual catheter navigation.
  • Willing and capable of attending scheduled follow up visits for the study duration = Willing and able to provide .

Exclusion criteria

Exclusion Criteria:

  • Atrial fibrillation is the target arrhythmia for the catheter ablation.
  • Unable to be safely exposed to the level of magnetic fields used for Robotic Magnetic Navigation
  • A history of sensitivity to foreign objects (gold, platinum/iridium, Pebax materials) 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.
  • Hemodynamic instability (to an extent that would make an interventional procedure high risk).
  • Presence of intracardiac thrombus.
  • Where MAGiC would need to cross a prosthetic valve.
  • Where MAGiC would need to be used in the coronary arteries.
  • Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation.
  • Acute myocardial infarct (within the previous 30 days).
  • Unstable angina at the time of enrollment.
  • History of embolism (cerebrovascular accident, , systemic embolism) in the previous 30 days.
  • Previous cardiac ablation within the last 30 days.
  • Inaccessible for follow-up visits for 6 months post ablation.
  • Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study.
  • Any reason or condition that, in the judgement of the investigator, makes the subject ineligible for the investigation.
Terms in these criteria, in plain language(2)

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • MAGiC CHD

    A patient requiring a cardiac ablation for SVT with CHD

    Device: Cardiac ablation using the MAGiC Ablation Catheter

Interventions

  • DeviceCardiac ablation using the MAGiC Ablation Catheter

    This MAGiC ablation catheter is used the the robotic Magnetic System to perform an ablation in a patient who has a SVT. Other patients who are not participaing in this study may have the same proceudre, the procedure with a different catheter, a procedure with a manual catheter, drug therapy or no treatment

06

What researchers measure

Primary outcomes

  1. Acute Success

    Non-indcability of Supraventricular Tachycardia (SVT)

    Time frame: Peri-procedural

  2. Chronic Success

    subjects free from the treated index arrhythmia through 6 months post procedure. To be counted as recurrence, the recurrent arrhythmia must be the same arrhythmia as primary index arrhythmia and must last at least 30 seconds on Holter monitor or event monitor recording, OR present on the entirety of a 12-lead ECG (minimum recording duration of 10 seconds) OR documented on a personal ECG device recording of a minimum of 30 seconds duration.

    Time frame: 6 months

  3. Acute Safety - Device or peocedure related adverse events

    Device or procedure related serioius adverse events which occurred prior to 7 days post-procedure

    Time frame: 7 days post procedure

Secondary outcomes

  1. Serious device related events

    All serious device related adverse events

    Time frame: 6 months

  2. Acute & Chronic Success

    Estimating acute procedural success and chronic success by type of target arrhythmia and by specific congenital defect and surgical repair.

    Time frame: 6 months

  3. Procedure time

    Characterize procedure time from insertion of first sheath to removal of last sheath

    Time frame: Peri-procedural

  4. Fluoroscopy Duration

    Review of Fluoroscopy duration

    Time frame: Peri-procedural

  5. Hospitlization

    Estimate the percentage of subjects free from the treated index arrhythmia or procedure related hospitalizations and major adverse events

    Time frame: 6 months

  6. Serious Advere Events

    Estimate the rate of subjects experiencing serious adverse events by event

    Time frame: 6 months

  7. Quality of Life and arrhythmia burden

    Estimate the change in subject quality of life and arrhythmia burden. Each question on the form is scored individually and a decreasein values would be considered that the pateint is doing better. The range for each question is from 0-8 or 0-9 dependng in the question

    Time frame: 6 months

  8. Unmet medical need

    Compilation of the anatomical and clinical challenges unique to the subject population, usage of the MAGiC catheter to address these challenges, and qualitative commentary on performance of MAGiC.

    Time frame: Peri-procedural

  9. Fluoroscopy Dose

    Review of the dose of DAP used during the procedure

    Time frame: Peri-procedural

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07812818
Lead sponsor
Stereotaxis
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Jan 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 10, 2026

Study contacts

Betsy Lowry
Contact
betsy.lowry@stereotaxis.com
973-723-6613
Aashi Mehrotra
Contact
aashi.mehrotra@stereotaxis.com
669-264-1433
Nathan McConkey, MD
principal investigator

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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