MultiPulse Therapy (MPT) for AF

NCT ID: NCT04206917

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-19
• Study Completion Date: 2022-06-21

Brief Summary

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

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.

Conditions

Atrial Fibrillation, Paroxysmal; Atrial Fibrillation, Persistent; Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Multi Pulse Therapy

Subjects will have AF induced and the Cardialen External Stimulation System (CESS) device will deliver electrical stimulation to terminate the arrhythmia.

Group Type: EXPERIMENTAL

Multi Pulse Therapy

Intervention Type: DEVICE

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.

Interventions

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 Type: DEVICE

Other Intervention Names

Unpinning Termination Therapy; Multi-stage therapy; Multi-stage electrotherapy; MultiPulse Therapy

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Avania

INDUSTRY

Sponsor Role: collaborator

Cardialen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PRASHANTHAN Sanders, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital - Adelaide Medical School

Locations

The Prince Charles Hospital

Chermside, Queensland, Australia

Gold Coast University Hospital

Gold Coast, Queensland, Australia

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

St. Andrews

Adelaide, South Australia, Australia

Mulgrave Private Hospital

Melbourne, Victoria, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 24076284 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21980076 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16945810 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20969974 (View on PubMed)

Other Identifiers

CL007

Identifier Type: -

Identifier Source: org_study_id