Atrial Fibrillation – Cardialen AF CL007
To assess the clinical safety and feasibility of MultiPulse Therapy (low voltage and energy used to terminate tachyarrhythmias) in subjects with paroxysmal and persistent Atrial Fibrillation (AF) during their clinically indicated atrial fibrillation catheter ablation procedure.
To be considered for the study you must meet the following criteria:
- Currently indicated for an atrial catheter ablation due to paroxysmal or persistent AF
- Aged between 18 and 80 years
- On current treatment and compliant with a standard anticoagulation regime
Your participation in this study would be for approximately 2 months.
Participants will be required to attend up to a total of 2 clinic visits (screening and procedure) and be available for a follow-up phone call at 30 days post-procedure.
During the screening visit, participant’s eligibility will be checked, their medical and medication history will be collected, a physical exam and routine echocardiogram will be performed and if applicable, a urine pregnancy test will be done.
Eligible participants will then undergo MultiPulse Therapy using the Cardialen External Stimulation System during their routine ablation procedure. Participants will have a follow-up assessment post-procedure at 30 days to collect information on any adverse events that may have occurred and their current health status. The 30-day follow-up visit can also be completed during a standard of care in-person clinic visit.