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.
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 Type
OBSERVATIONAL
Enrollment
40
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
Acute Success
Non-indcability of Supraventricular Tachycardia (SVT)
Time frame: 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.
Time frame: 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
Time frame: 7 days post procedure
Serious device related events
All serious device related adverse events
Time frame: 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.
Time frame: 6 months
Procedure time
Characterize procedure time from insertion of first sheath to removal of last sheath
Time frame: Peri-procedural
Fluoroscopy Duration
Review of Fluoroscopy duration
Time frame: Peri-procedural
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Hospitlization
Estimate the percentage of subjects free from the treated index arrhythmia or procedure related hospitalizations and major adverse events
Time frame: 6 months
Serious Advere Events
Estimate the rate of subjects experiencing serious adverse events by event
Time frame: 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
Time frame: 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.
Time frame: Peri-procedural
Fluoroscopy Dose
Review of the dose of DAP used during the procedure
Time frame: Peri-procedural