MultiPulse Therapy (MPT) for AF

NCT04206917 | Terminated FDA Device

• 1 other identifier: CL007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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)

• To define the safety of MPT for the treatment of atrial fibrillation in subjects

  Adverse Events from procedure and 30 day follow up.

  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)

  Study procedure

• Translation

  Determine MPT parameters relationships at which MPT terminates AF

  Study procedure

• Translation

  Determine rate of conversion from AF to NSR after MPT delivery

  Study procedure

Study Arms (1)

Multi Pulse Therapy

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

Interventions

Multi Pulse Therapy 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.

Also known as: Unpinning Termination Therapy, Multi-stage therapy, Multi-stage electrotherapy, MultiPulse Therapy

Multi Pulse Therapy

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 globally accepted risk stratification (CHA2DS2-VASc score) and 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\<20%
• NYHA Class 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
• Avania: collaborator

Study Sites (6)

The Prince Charles Hospital

Chermside, Queensland, Australia

Location

Gold Coast University Hospital

Gold Coast, Queensland, Australia

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

St. Andrews

Adelaide, South Australia, Australia

Location

Mulgrave Private Hospital

Melbourne, Victoria, 3170, Australia

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

• PRASHANTHAN Sanders, MD

  Royal Adelaide Hospital - Adelaide Medical School

  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: Cardialen External Stimulation System (CESS) V1.0

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: December 20, 2019
• Study Start: March 19, 2020
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)