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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04939584




Registration number
NCT04939584
Ethics application status
Date submitted
10/06/2021
Date registered
25/06/2021

Titles & IDs
Public title
Patient Perception of MultiPulse Therapy™ (MPT™)
Scientific title
A Clinical Feasibility Study to Evaluate Patient Perception of MPT
Secondary ID [1] 0 0
CL008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Therapy acceptance as measured by a subject question administered immediately following MPT delivery
Timepoint [1] 0 0
Immediately following MPT delivery
Primary outcome [2] 0 0
Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery
Timepoint [2] 0 0
Immediately following MPT delivery
Secondary outcome [1] 0 0
Safety determined from summary report of Adverse Events
Timepoint [1] 0 0
Through 30 days post-intervention

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2022
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
St. Andrew's Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cardialen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04939584