Patient Perception of MultiPulse Therapy™ (MPT™)

NCT ID: NCT04939584

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-19
• Study Completion Date: 2022-10-01

Brief Summary

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

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.

Conditions

Atrial Fibrillation

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

MultiPulse Therapy

Intervention Type: DEVICE

Electrical Stimulation

Interventions

MultiPulse Therapy

Electrical Stimulation

Intervention Type: DEVICE

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. 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

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

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

Sponsors

Cardialen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Adelaide Hospital

Adelaide, South Australia, Australia

St. Andrew's Hospital

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

CL008

Identifier Type: -

Identifier Source: org_study_id