Supraventricular Tachycardia (SVT)MAGiC-CHDNCT07812818
MAGiC - Congenital Heart DIsease
An observational study of Supraventricular Tachycardia (SVT) and Congenital Heart Disease (CHD), run by Stereotaxis.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraventricular Tachycardia (SVT), Congenital Heart Disease (CHD)
- What is being tested?
- Cardiac ablation using the MAGiC Ablation Catheter
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Dec 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
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
Who may be able to join
- 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 informed consent.
Who cannot join
- 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).
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- 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, transient ischemic attack, 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The MAGiC™ Ablation Catheter in Congenital Heart Disease Arrhythmias Post-Approval Study
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.
- Being tested
- Cardiac ablation using the MAGiC Ablation Catheter
- Keywords
- cardiac ablation
- Medical subject headings
- Tachycardia, Supraventricular, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac ablation using the MAGiC Ablation CatheterDevice
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
| Study group | Role | What they receive |
|---|---|---|
| MAGiC CHD | A patient requiring a cardiac ablation for SVT with CHD Receives: Device: Cardiac ablation using the MAGiC Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Success
Non-indcability of Supraventricular Tachycardia (SVT)
Measured: Peri-procedural
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.
Measured: 6 months
Acute Safety - Device or peocedure related adverse events
Device or procedure related serioius adverse events which occurred prior to 7 days post-procedure
Measured: 7 days post procedure
Secondary outcomes (9)
Serious device related events
All serious device related adverse events
Measured: 6 months
Acute & Chronic Success
Estimating acute procedural success and chronic success by type of target arrhythmia and by specific congenital defect and surgical repair.
Measured: 6 months
Procedure time
Characterize procedure time from insertion of first sheath to removal of last sheath
Measured: Peri-procedural
Fluoroscopy Duration
Review of Fluoroscopy duration
Measured: Peri-procedural
Hospitlization
Estimate the percentage of subjects free from the treated index arrhythmia or procedure related hospitalizations and major adverse events
Measured: 6 months
Serious Advere Events
Estimate the rate of subjects experiencing serious adverse events by event
Measured: 6 months
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
Measured: 6 months
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.
Measured: Peri-procedural
Fluoroscopy Dose
Review of the dose of DAP used during the procedure
Measured: Peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular Tachycardia (SVT)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Stereotaxis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan McConkey, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812818
- Sponsor's protocol ID
- MCHD-001
- Acronym
- MAGiC-CHD
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MAGiC™ Ablation Catheter in Congenital Heart Disease Arrhythmias Post-Approval Study
- ClinicalTrials.gov ID
- NCT07812818
- Acronym / sponsor ID
- MAGiC-CHD / MCHD-001
- Keywords
- cardiac ablation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- StereotaxisIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Sep 2026 (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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAGiC CHD | – | Device: Cardiac ablation using the MAGiC Ablation CatheterA patient requiring a cardiac ablation for SVT with CHD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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 informed consent.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| Cardiac ablation using the MAGiC Ablation CatheterThis 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 | Device | MAGiC CHD |
Primary outcome
Acute Success
Time frame: Peri-procedural
Non-indcability of Supraventricular Tachycardia (SVT)
Chronic Success
Time frame: 6 months
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.
Acute Safety - Device or peocedure related adverse events
Time frame: 7 days post procedure
Device or procedure related serioius adverse events which occurred prior to 7 days post-procedure
9 secondary outcomes
Serious device related events
Time frame: 6 months
Acute & Chronic Success
Time frame: 6 months
Procedure time
Time frame: Peri-procedural
Fluoroscopy Duration
Time frame: Peri-procedural
Hospitlization
Time frame: 6 months
Serious Advere Events
Time frame: 6 months
Quality of Life and arrhythmia burden
Time frame: 6 months
Unmet medical need
Time frame: Peri-procedural
Fluoroscopy Dose
Time frame: Peri-procedural
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 10 Sep 2026.
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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.
Nathan McConkey, MD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Supraventricular Tachycardia (SVT) and Congenital Heart Disease (CHD), run by Stereotaxis.
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 4 inclusion and 17 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (973-723-6613, 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 Success (time frame: Peri-procedural). The study lists 3 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 10 Sep 2026.