MAGiC - Congenital Heart DIsease

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.

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.

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 informed consent.

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, 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.