MAGiC - Congenital Heart DIsease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStereotaxis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiac ablation using the MAGiC Ablation Catheter
DeviceThis 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
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: MAGiC CHD1 intervention
Trial outcomes
Primary outcomes
1
Acute Success
Non-indcability of Supraventricular Tachycardia (SVT)
Time frame
Peri-procedural2
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 months3
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 procedureSecondary outcomes
1
Serious device related events
All serious device related adverse events
Time frame
6 months2
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 months3
Procedure time
Characterize procedure time from insertion of first sheath to removal of last sheath
Time frame
Peri-procedural4
Fluoroscopy Duration
Review of Fluoroscopy duration
Time frame
Peri-proceduralLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: