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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04206917




Registration number
NCT04206917
Ethics application status
Date submitted
23/10/2019
Date registered
20/12/2019
Date last updated
15/07/2020

Titles & IDs
Public title
MultiPulse Therapy (MPT) for AF
Scientific title
A Clinical Feasibility Study to Evaluate the Safety and Performance of Low-Energy Therapy in Patients With Atrial Fibrillation Energy Therapy in Patients With Atrial Fibrillation
Secondary ID [1] 0 0
CL007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation, Paroxysmal 0 0
Atrial Fibrillation, Persistent 0 0
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 - Multi Pulse Therapy

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.


Treatment: Devices: Multi 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To define the safety of MPT for the treatment of atrial fibrillation in subjects - Adverse Events from procedure and 30 day follow up.
Timepoint [1] 0 0
Study procedure and 30 day post procedure
Primary outcome [2] 0 0
Translation - Explore and enhance MPT parameters delivered in successful cases in a previous Cardialen AF study (CL001 / NCT02257112)
Timepoint [2] 0 0
Study procedure
Primary outcome [3] 0 0
Translation - Determine MPT parameters relationships at which MPT terminates AF
Timepoint [3] 0 0
Study procedure
Primary outcome [4] 0 0
Translation - Determine rate of conversion from AF to NSR after MPT delivery
Timepoint [4] 0 0
Study procedure

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. 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
Minimum age
18 Years
Maximum age
80 Years
Gender
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. 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

Study design
Purpose of the study
Device Feasibility
Allocation to intervention
N/A
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
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Mulgrave Private Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4120 - Greenslopes
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3170 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cardialen, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Genae
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Five Corners
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Assess the clinical safety and feasibility of MultiPulse Therapy (MPT) electrical stimulation
waveform sequence in terminating paroxysmal and persistent atrial fibrillation.
Trial website
https://clinicaltrials.gov/show/NCT04206917
Trial related presentations / 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.
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.
Efimov I, Ripplinger CM. Virtual electrode hypothesis of defibrillation. Heart Rhythm. 2006 Sep;3(9):1100-2. Epub 2006 Mar 10.
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.
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
Dave Munneke, MS
Address 0 0
Country 0 0
Phone 0 0
6128049516
Fax 0 0
Email 0 0
DMunneke@cardialen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04206917