Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
A prospective non-randomized feasibility study involving acute testing of MPT in subjects with paroxysmal and persistent AF during clinically indicated atrial fibrillation catheter ablation procedure. Subjects will be split into 2 cohorts depending on status at time of procedure. 1. In Atrial Fibrillation at time of procedure (Clinical AF) 2. In Normal Sinus Rhythm at time of procedure Subjects will be evaluated at the visits for the Clinically-Indicated Procedure per standard of care. A single follow-up at up to 30 days post-procedure is required to assess subjects for adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
30
The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen MultiPulse Therapy (MPT). The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.
The Prince Charles Hospital
Chermside, Queensland, Australia
Gold Coast University Hospital
Gold Coast, Queensland, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
To define the safety of MPT for the treatment of atrial fibrillation in subjects
Adverse Events from procedure and 30 day follow up.
Time frame: Study procedure and 30 day post procedure
Translation
Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)
Time frame: Study procedure
Translation
Determine MPT parameters relationships at which MPT terminates AF
Time frame: Study procedure
Translation
Determine rate of conversion from AF to NSR after MPT delivery
Time frame: Study procedure
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St. Andrews
Adelaide, South Australia, Australia
Mulgrave Private Hospital
Melbourne, Victoria, Australia