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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P240014 / PAS001 |
| Date Original Protocol Accepted |
07/31/2026
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| Date Current Protocol Accepted |
07/31/2026
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| Study Name |
MAGiC-CHD Post-Approval Study
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| Device Name |
MAGiC Ablation Catheter
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| Clinical Trial Number(s) |
NCT06019845
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The MAGiC-CHD Post-Approval Study is a prospective, nonrandomized, 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.
The objective of MAGiC-CHD is to collect device-related Major Adverse Events, and acute and chronic success rates with MAGiC in subjects with CHD being treated for a cardiac arrhythmia.
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| Study Population |
Adult patients with congenital heart disease (CHD) and limited vascular access or difficult access to the target cardiac chamber.
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| Sample Size |
Number of subjects: 40
Assumptions for sample size estimation:
Number of sites: 10
Sites location: TBA
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| Key Study Endpoints |
Safety Endpoints
Safety will be assessed by the rate of device- or procedure-related serious adverse events through 7 days post procedure.
Effectiveness Endpoints
The primary endpoint is: 1. to estimate the rate of acute procedural success, defined as the percentage of patients with successful resolution of the treated index arrhythmia at the end of the procedure; and 2. to estimate the rate of chronic success through 6 months post-procedure, defined as the percentage of patients free
from documented sustained recurrence of the treated index arrhythmia.
Additional endpoints will be collected and reported:
¿ Rate of serious adverse events related to the MAGiC Ablation Catheter
¿ Acute procedural success and chronic success by type of target arrhythmia and by specific congenital defect and surgical repair.
¿ Arrhythmia or procedure related hospitalization and major adverse events through 6 months follow-up.
¿ All serious adverse events for severity, relatedness and outcome.
¿ Procedure Details
o Procedure time (groin puncture to removal of all sheaths)
o Total fluoroscopy time and dose
¿ Estimating the change in patient quality of life and arrhythmia burden.
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| Follow-up Visits and Length of Follow-up |
Follow-up clinical data will be collected at discharge, 7 days, 1 month, and 6 months post-procedure.
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