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TerminatedNCT04206917Updated Oct 14, 2022

MultiPulse Therapy (MPT) for AF

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

Why this study was terminated
Sponsor ceasing operations

From the registry’s dates

  • Primary completion was Jun 2022, 4 years 3 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Atrial Fibrillation, Paroxysmal
  • Atrial Fibrillation, Persistent
  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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 globally accepted risk stratification (CHA2DS2-VASc score) and the Principal Investigator

Exclusion criteria

Exclusion Criteria:

  1. Life expectancy of 1 year or less
  2. AF due to reversible causes (e.g., hyperthyroidism, valve disease)
  3. History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm
  4. Currently in AF for more than 3 months continuously
  5. Chronic, long-standing persistent, or permanent atrial fibrillation
  6. Allergy or contraindication to anticoagulation therapy
  7. Presence of intracardiac thrombus (confirmed with TEE or ICE)
  8. Existing Left Atrial Appendage closure device
  9. Severely Dilated Left Atrium >5cm
  10. LVEF\<20%
  11. NYHA Class IV heart failure at the time of enrollment
  12. History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
  13. Known hyper-coagulable state that increases risk of thrombus
  14. History of myocardial infarction or coronary revascularization within the preceding 3 months.
  15. History of sustained ventricular arrhythmia or cardiac arrest
  16. Presence of chronically implanted lead in the CS
  17. Presence of ventricular assist device, including intra-aortic balloon pump
  18. Documented bradycardia (\<40 BPM) at the time of the study
  19. Morbid obesity: BMI>39 kg/m2
  20. Presence of any prosthetic cardiac valve
  21. History of significant tricuspid valvular disease requiring surgery
  22. Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
  23. Cognitive or mental health status that would interfere with study participation and proper informed consent
  24. 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
  25. Pregnancy confirmed by test within 7 days of procedure.
  26. Inability to pass catheters to heart due to vascular limitations
  27. 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)
  28. No active endocarditis
  29. Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
  30. History of hemodynamic compromise due to valvular heart disease
  31. Unstable CAD as determined by the investigator
  32. Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigators
  33. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
  34. Any other condition which may affect the outcome of this study or safety of the subject as determined by the investigator
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Multi Pulse Therapy

    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

  • DeviceMulti 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

06

What researchers measure

Primary outcomes

  1. 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

  2. Translation

    Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)

    Time frame: Study procedure

  3. Translation

    Determine MPT parameters relationships at which MPT terminates AF

    Time frame: Study procedure

  4. Translation

    Determine rate of conversion from AF to NSR after MPT delivery

    Time frame: Study procedure

07

Study locations

6 sites
  • The Prince Charles Hospital
    Chermside, Queensland, Australia
  • Gold Coast University Hospital
    Gold Coast, Queensland, Australia
  • Greenslopes Private Hospital
    Greenslopes, Queensland 4120, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • St. Andrews
    Adelaide, South Australia, Australia
  • Mulgrave Private Hospital
    Melbourne, Victoria 3170, Australia
08

References and documents

Publications

  • 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. PubMed 24076284 ↗
  • 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. PubMed 21980076 ↗
  • 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. PubMed 16945810 ↗
  • 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. PubMed 20969974 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04206917
Lead sponsor
Cardialen, Inc.
Collaborators
Iqvia Pty Ltd, Avania
Responsible party
Sponsor
First posted
Dec 20, 2019
Start date
Mar 19, 2020
Primary completion
Jun 21, 2022
Completion
Jun 21, 2022
Last update
Oct 14, 2022

Study contacts

PRASHANTHAN Sanders, MD
principal investigator · Royal Adelaide Hospital - Adelaide Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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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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