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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04939584
Registration number
NCT04939584
Ethics application status
Date submitted
10/06/2021
Date registered
25/06/2021
Date last updated
10/10/2022
Titles & IDs
Public title
Patient Perception of MultiPulse Therapy™ (MPT™)
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Scientific title
A Clinical Feasibility Study to Evaluate Patient Perception of MPT
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Secondary ID [1]
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CL008
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MultiPulse Therapy
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.
Treatment: Devices: MultiPulse Therapy
Electrical Stimulation
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Therapy acceptance as measured by a subject question administered immediately following MPT delivery
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Assessment method [1]
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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."
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Timepoint [1]
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Immediately following MPT delivery
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Primary outcome [2]
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Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery
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Assessment method [2]
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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."?
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Timepoint [2]
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Immediately following MPT delivery
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Secondary outcome [1]
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Safety determined from summary report of Adverse Events
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Assessment method [1]
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Adverse Event frequency by Adverse Event type
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Timepoint [1]
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Through 30 days post-intervention
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2022
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Sample size
Target
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Accrual to date
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Final
6
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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St. Andrew's Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cardialen, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Assess the subject acceptance of MPT, using therapy parameters that have been shown to be
effective in terminating episodes of atrial fibrillation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04939584
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04939584
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