Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Brief summary
Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
Detailed description
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.
Interventions
DEVICEMulti Pulse Therapy as delivered from the Cardialen External Stimulation System
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
Sponsors
Iqvia Pty Ltd
Cardialen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Multi-Pulse Therapy as delivered from the Cardialen External Stimulation System (CESS)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between 18 and 80 years of age 2. Willing and able to comply with the study protocol, provide a written informed consent 3. Currently indicated for atrial catheter ablation due to paroxysmal or early persistent atrial fibrillation 4. Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by the Principal Investigator
Exclusion criteria
The subject must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety of MPT for the treatment of atrial fibrillation in subjects | Acutely at the time of the study procedure | Reported Adverse Events following MPT delivery |
| Enhanced ability of MPT to stop atrial fibrillation | Acutely following MPT delivery | Compare voltages at which MPT successfully terminated AF against a previous Cardialen AF study (CL001 / NCT02257112) |
| Ability of MPT to stop atrial fibrillation | Acutely following MPT delivery | Determine rate of conversion from AF to NSR |
Countries
United States
Outcome results
None listed