Patient Perception of MultiPulse Therapy™ (MPT™)

NCT04939584 | Terminated FDA Device

• 1 other identifier: CL008
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety determined from summary report of Adverse Events

  Through 30 days post-intervention

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

MultiPulse Therapy DEVICE

Electrical Stimulation

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between 18 and 80 years of age
• Willing and able to comply with the study protocol, provide a written informed consent
• History of Atrial Fibrillation in past 12 months
• Indicated to undergo an acute electrophysiology procedure allowing for conscious participation in the clinical study
• 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:
• a. History of DC-Cardioversion in past 12 months: With or Without
• b. AFEQT Score: \<=89
• Study stage dependent: Stage 2 (based on results from study stage 1):
• a: History of DC-Cardioversion in past 12 months: Potential emphasis on patients with history of DCCV
• b. AFEQT Score: Potential emphasis on patients with AFEQT \<= 58

You may not qualify if:

• Life expectancy of 1 year or less
• AF due to reversible causes (e.g., hyperthyroidism, valve disease)
• Hx of fibromyalgia or any other evidence of wide-spread pain
• Any current pain condition that could be confused with pain or discomfort associated with MPT
• \>1 current well-defined pain condition (e.g., migraine, joint OA, painful diabetic neuropathy)
• Use of any opioid analgesic (including tramadol) within 3 months of screening
• Spielberger's STAI-AD-Trait \> 75
• AFEQT: Section 1: "I was never aware of having atrial fibrillation" is checked
• Allergy or contraindication to anticoagulation therapy
• Presence of intracardiac thrombus (confirmed with cardiac imaging)
• Existing Left Atrial Appendage closure device
• LVEF\<20%
• NYHA Class IV heart failure at the time of enrollment
• History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolic event within the preceding 3 months.
• Known hyper-coagulable state that increases risk of thrombus

Sponsors & Collaborators

• Cardialen, Inc.: lead

Study Sites (2)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

St. Andrew's Hospital

Adelaide, South Australia, Australia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 25, 2021
• Study Start: November 19, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)