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Patient Perception of MultiPulse Therapy™ (MPT™)

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ClinicalTrials.gov Identifier: NCT04939584
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Cardialen, Inc.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Clinical Feasibility Study to Evaluate Patient Perception of MPT
Actual Study Start Date : November 19, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Therapy acceptance as measured by a subject question administered immediately following MPT delivery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through 30 days post-intervention ]
    Adverse Event frequency by Adverse Event type



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939584


Contacts
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Contact: Thomas M Rasmussen 7196596363 trasmussen@cardialen.com

Locations
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Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Jun Lin       jun.lin@adelaide.edu.au   
Principal Investigator: Prash Sanders, MD         
St. Andrew's Hospital Recruiting
Adelaide, South Australia, Australia
Contact: Rebecca A Collins       Rebecca.Collins@genesiscare.com   
Principal Investigator: Glenn Young, MD         
Sponsors and Collaborators
Cardialen, Inc.
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Responsible Party: Cardialen, Inc.
ClinicalTrials.gov Identifier: NCT04939584    
Other Study ID Numbers: CL008
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Cardialen, Inc.:
Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes