Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation
Brief summary
Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.
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.
Interventions
DEVICEMultiPulse Therapy
Electrical Stimulation
Sponsors
Cardialen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Safety determined from summary report of Adverse Events | Through 30 days post-intervention | Adverse Event frequency by Adverse Event type |
Countries
Australia
Outcome results
None listed