An interventional study of Multi Pulse Therapy in Atrial Fibrillation, Paroxysmal, Atrial Fibrillation, Persistent and Atrial Fibrillation, sponsored by Cardialen, Inc.. Terminated at 6 sites in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-14.
Sponsored by Cardialen, Inc. · Not applicable, Interventional, and Device feasibility
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 30 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Cardialen, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.
Device: Multi Pulse Therapy
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.
Also known as: Unpinning Termination Therapy, Multi-stage therapy, Multi-stage electrotherapy, MultiPulse Therapy
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
Plan to share: No
This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Cardialen, Inc.