Patient Perception of MultiPulse Therapy™ (MPT™)

• Sponsor: Cardialen, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04939584
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 9.4
• Patients Per Site: 10
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: MultiPulse Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective non-randomized feasibility study involving acute evaluation of the perception and acceptance of MPT as a therapy to stop episodes of AF in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure).A prospective non-randomized feasibility study involving acute evaluation of the perception and acceptance of MPT as a therapy to stop episodes of AF in subjects having a history of AF during clinically indicated acute electrophysiology procedures including AF ablation, SVT ablation or diagnostic EP procedures (indicated procedure).
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Clinical Feasibility Study to Evaluate Patient Perception of MPT
• Actual Study Start Date: Nov 19, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

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.

Device: MultiPulse Therapy; Electrical Stimulation

Outcome Measures

Primary Outcome Measures

1. Therapy acceptance as measured by a subject question administered immediately following MPT delivery [Immediately following MPT delivery]

   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."

2. Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery [Immediately following MPT delivery]

   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."?

Secondary Outcome Measures

1. Safety determined from summary report of Adverse Events [Through 30 days post-intervention]

   Adverse Event frequency by Adverse Event type

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Adelaide Hospital	Adelaide	South Australia	Australia
2	St. Andrew's Hospital	Adelaide	South Australia	Australia

Sponsors and Collaborators

• Cardialen, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cardialen, Inc.
• ClinicalTrials.gov Identifier: NCT04939584
• Other Study ID Numbers: CL008
• First Posted: Jun 25, 2021
• Last Update Posted: Mar 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Cardialen, Inc.: Atrial Fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Mar 15, 2022