MultiPulse Therapy (MPT) for AF (US)

Study Overview
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Brief Summary
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Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation waveform sequence in terminating paroxysmal and persistent atrial fibrillation.

Detailed Description
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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. In Atrial Fibrillation at time of procedure (Clinical AF) 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.

Official Title
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A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation (US)

Conditions
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Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Multi Pulse Therapy as delivered from the Cardialen External Stimulation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between 18 and 80 years of age Willing and able to comply with the study protocol, provide a written informed consent Currently indicated for atrial catheter ablation due to paroxysmal or early persistent atrial fibrillation 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 exclusion criteria: Life expectancy of 1 year or less AF due to reversible causes (e.g., hyperthyroidism, valve disease) History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm Currently in AF for more than 3 months continuously Chronic, long-standing persistent, or permanent atrial fibrillation Allergy or contraindication to anticoagulation therapy Presence of intracardiac thrombus (confirmed with TEE or ICE) Existing Left Atrial Appendage closure device Severely Dilated Left Atrium >5cm LVEF<35% NYHA Class III or IV heart failure at the time of enrollment History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months. Known hyper-coagulable state that increases risk of thrombus History of myocardial infarction or coronary revascularization within the preceding 3 months. History of sustained ventricular arrhythmia or cardiac arrest Presence of chronically implanted lead in the CS Presence of ventricular assist device, including intra-aortic balloon pump Documented bradycardia (<40 BPM) at the time of the study Morbid obesity: BMI>39 kg/m2 Presence of any prosthetic cardiac valve History of significant tricuspid valvular disease requiring surgery Moderate to severe mitral valve regurgitation (>40% regurgitation fraction) Cognitive or mental health status that would interfere with study participation and proper informed consent Cardiovascular anatomical defects that would complicate placement of the stimulation leads required by the protocol, including congenital heart disease and cardiac vein anomalies per the Investigator's discretion Pregnancy confirmed by test within 7 days of procedure. Inability to pass catheters to heart due to vascular limitations Cardiovascular surgery or intervention within 1 month prior to enrollment or planned for up to 1 month after enrollment (other than the planned treatment procedure) Active endocarditis Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator History of hemodynamic compromise due to valvular heart disease Unstable CAD as determined by the investigator Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Multi-Pulse Therapy as delivered from the Cardialen External Stimulation System (CESS)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi Pulse Therapy as delivered from the Cardialen External Stimulation System<br>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 as delivered from the Cardialen External Stimulation System<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of MPT for the treatment of atrial fibrillation in subjects | Reported Adverse Events following MPT delivery | 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 | 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) | Acutely following MPT delivery | 
| Ability of MPT to stop atrial fibrillation | Determine rate of conversion from AF to NSR | Acutely following MPT delivery |