Patient Perception of MultiPulse Therapy™ (MPT™)

A Clinical Feasibility Study to Evaluate Patient Perception of MPT

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

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: MultiPulse Therapy

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia
      • Royal Adelaide Hospital
    • Adelaide, South Australia, Australia
      • St. Andrew's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapy acceptance as measured by a subject question administered 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."	Immediately following MPT delivery
Subject perception of MPT as measured by a pain scale administered 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."?	Immediately following MPT delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety determined from summary report of Adverse Events	Adverse Event frequency by Adverse Event type	Through 30 days post-intervention

Collaborators and Investigators

• Sponsor: Cardialen, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CL008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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