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TerminatedNCT04939584Updated Oct 10, 2022

Patient Perception of MultiPulse Therapy™ (MPT™)

An interventional study of MultiPulse Therapy in Atrial Fibrillation, sponsored by Cardialen, Inc.. Terminated at 2 sites in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-10.

Sponsored by Cardialen, Inc. · Not applicable, Interventional, and Other

Why this study was terminated
Sponsor ceased operations

From the registry’s dates

  • Primary completion was Oct 2022, 4 years ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.

Read the detailed description

A prospective non-randomized feasibility study involving acute testing of MPT in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure). The primary outcome of the study is the subject response to questions regarding perception and acceptability following MPT delivery.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial Fibrillation
03

In context

Atrial Fibrillation

3,958 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 6 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Cardialen, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. History of Atrial Fibrillation in past 12 months
  4. Indicated to undergo an acute electrophysiology procedure allowing for conscious participation in the clinical study
  5. Current treatment and compliance with standard anticoagulation regimen, including uninterrupted OAC, with acceptable coagulation status, as determined by the Principal Investigator

Study stage dependent: Stage 1:

6a. History of DC-Cardioversion in past 12 months: With or Without

7b. AFEQT Score: \<=89

Study stage dependent: Stage 2 (based on results from study stage 1):

6a: History of DC-Cardioversion in past 12 months: Potential emphasis on patients with history of DCCV

7b. AFEQT Score: Potential emphasis on patients with AFEQT \<= 58

Exclusion criteria

Exclusion Criteria:

  1. Life expectancy of 1 year or less
  2. AF due to reversible causes (e.g., hyperthyroidism, valve disease)
  3. Hx of fibromyalgia or any other evidence of wide-spread pain
  4. Any current pain condition that could be confused with pain or discomfort associated with MPT
  5. >1 current well-defined pain condition (e.g., migraine, joint OA, painful diabetic neuropathy)
  6. Use of any opioid analgesic (including tramadol) within 3 months of screening
  7. Spielberger's STAI-AD-Trait > 75
  8. AFEQT: Section 1: "I was never aware of having atrial fibrillation" is checked
  9. Allergy or contraindication to anticoagulation therapy
  10. Presence of intracardiac thrombus (confirmed with cardiac imaging)
  11. Existing Left Atrial Appendage closure device
  12. LVEF\<20%
  13. NYHA Class IV heart failure at the time of enrollment
  14. History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
  15. Known hyper-coagulable state that increases risk of thrombus
  16. History of myocardial infarction or coronary revascularization within the preceding 3 months.
  17. History of sustained ventricular arrhythmia or cardiac arrest
  18. Presence of chronically implanted lead in the CS
  19. Presence of ventricular assist device, including intra-aortic balloon pump
  20. Documented bradycardia (\<40 BPM) at the time of the study
  21. Morbid obesity: BMI>39 kg/m2
  22. Presence of any prosthetic cardiac valve
  23. History of significant tricuspid valvular disease requiring surgery
  24. Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
  25. Cognitive or mental health status that would interfere with study participation and proper informed consent
  26. 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
  27. Pregnancy confirmed by test within 7 days of procedure.
  28. Inability to pass catheters to heart due to vascular limitations
  29. 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)
  30. Active endocarditis
  31. History of hemodynamic compromise due to valvular heart disease
  32. Unstable CAD as determined by the investigator
  33. Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator
  34. History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
  35. Any other medical 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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Intervention

    The study will be conducted using the venous cannulations that are standard of care for the indicated procedure. Additional access points may be necessary if access to coronary sinus is difficult from existing femoral venous cannulations. Sterile study leads or EP catheters will be temporarily placed into the RA, CS, and RV (for R-wave sensing using intracardiac electrograms - optional) which will be connected to the investigational device (CESS). Up to two MPTs will be delivered and subject responses following each MPT regarding perception and acceptability of MPT to treat AF will be obtained. MPT voltages will not exceed 100V.

    Device: MultiPulse Therapy

Interventions

  • DeviceMultiPulse Therapy

    Electrical Stimulation

06

What researchers measure

Primary outcomes

  1. Therapy acceptance as measured by a subject question administered immediately following MPT delivery

    Question: "Now I want you to think about your experiences with Atrial Fibrillation. Think about how it makes you feel, your daily life while in atrial fibrillation and your experience with in-clinic treatments for atrial fibrillation. If you could use the stimulation you just felt at home and under your control, would you use this stimulation therapy to stop your atrial fibrillation? Please answer yes or no."

    Time frame: Immediately following MPT delivery

  2. Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery

    Question: "Please rate any pain you experienced at the time of the stimulus, was it: No pain, mild pain, moderate pain, severe pain, the worst possible pain imaginable."?

    Time frame: Immediately following MPT delivery

Secondary outcomes

  1. Safety determined from summary report of Adverse Events

    Adverse Event frequency by Adverse Event type

    Time frame: Through 30 days post-intervention

07

Study locations

2 sites
  • Royal Adelaide Hospital
    Adelaide, South Australia, Australia
  • St. Andrew's Hospital
    Adelaide, South Australia, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2021 to primary completion in Oct 2022, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2021
First posted
Jun 25, 2021
StartActual
Nov 19, 2021
Primary completionActual
Oct 1, 2022
CompletionActual
Oct 1, 2022
Last update
Oct 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04939584
Lead sponsor
Cardialen, Inc.
Responsible party
Sponsor
First posted
Jun 25, 2021
Start date
Nov 19, 2021
Primary completion
Oct 1, 2022
Completion
Oct 1, 2022
Last update
Oct 10, 2022

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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