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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04939584
Other study ID # CL008
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 19, 2021
Est. completion date October 1, 2022

Study information

Verified date October 2022
Source Cardialen, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date October 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
MultiPulse Therapy
Electrical Stimulation

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia St. Andrew's Hospital Adelaide South Australia

Sponsors (1)

Lead Sponsor Collaborator
Cardialen, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Safety determined from summary report of Adverse Events Adverse Event frequency by Adverse Event type Through 30 days post-intervention
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