MultiPulse Therapy (MPT) for AF (US)

NCT05055921 | Terminated FDA Device

• 1 other identifier: CL007 (US)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Multi Pulse Therapy as delivered from the Cardialen External Stimulation System

EXPERIMENTAL

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

Interventions

Multi Pulse Therapy as delivered from the Cardialen External Stimulation System DEVICE

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

Multi Pulse Therapy as delivered from the Cardialen External Stimulation System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardialen, Inc.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (2)

Minneapolis Veterans Administration Hospital

Minneapolis, Minnesota, 55417, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

• Janardhan AH, Gutbrod SR, Li W, Lang D, Schuessler RB, Efimov IR. Multistage electrotherapy delivered through chronically-implanted leads terminates atrial fibrillation with lower energy than a single biphasic shock. J Am Coll Cardiol. 2014 Jan 7-14;63(1):40-8. doi: 10.1016/j.jacc.2013.07.098. Epub 2013 Sep 26.

  PMID: 24076284 BACKGROUND

• Li W, Janardhan AH, Fedorov VV, Sha Q, Schuessler RB, Efimov IR. Low-energy multistage atrial defibrillation therapy terminates atrial fibrillation with less energy than a single shock. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):917-25. doi: 10.1161/CIRCEP.111.965830. Epub 2011 Oct 6.

  PMID: 21980076 BACKGROUND

• Efimov I, Ripplinger CM. Virtual electrode hypothesis of defibrillation. Heart Rhythm. 2006 Sep;3(9):1100-2. doi: 10.1016/j.hrthm.2006.03.005. Epub 2006 Mar 10. No abstract available.

  PMID: 16945810 BACKGROUND

• Ambrosi CM, Ripplinger CM, Efimov IR, Fedorov VV. Termination of sustained atrial flutter and fibrillation using low-voltage multiple-shock therapy. Heart Rhythm. 2011 Jan;8(1):101-8. doi: 10.1016/j.hrthm.2010.10.018. Epub 2010 Oct 19.

  PMID: 20969974 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John D Hummel, MD

  Ohio State University (OSU) Wexner Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-Pulse Therapy as delivered from the Cardialen External Stimulation System (CESS)

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: September 24, 2021
• Study Start: February 28, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)