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
6
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. Other Names: * Unpinning Termination Therapy * Multi-stage therapy * Multi-stage electrotherapy * MultiPulse Therapy
Minneapolis Veterans Administration Hospital
Minneapolis, Minnesota, United States
The Ohio State University
Columbus, Ohio, United States
The safety of MPT for the treatment of atrial fibrillation in subjects
Reported Adverse Events following MPT delivery
Time frame: Acutely at the time of the study procedure
The safety of MPT for the treatment of atrial fibrillation in subjects
Reported Adverse Events following MPT delivery
Time frame: At 30 day post procedure
Enhanced ability of MPT to stop atrial fibrillation
Compare voltages at which MPT successfully terminated AF against a previous Cardialen AF study (CL001 / NCT02257112)
Time frame: Acutely following MPT delivery
Ability of MPT to stop atrial fibrillation
Determine rate of conversion from AF to NSR
Time frame: Acutely following MPT delivery
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