Patient Perception of MultiPulse Therapy™ (MPT™)
Atrial Fibrillation
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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:
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:
- 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
- History of myocardial infarction or coronary revascularization within the preceding 3 months.
- History of sustained ventricular arrhythmia or cardiac arrest
- Presence of chronically implanted lead in the CS
- Presence of ventricular assist device, including intra-aortic balloon pump
- Documented bradycardia (<40 BPM) at the time of the study
- Morbid obesity: BMI>39 kg/m2
- Presence of any prosthetic cardiac valve
- History of significant tricuspid valvular disease requiring surgery
- Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
- Cognitive or mental health status that would interfere with study participation and proper informed consent
- 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
- Pregnancy confirmed by test within 7 days of procedure.
- Inability to pass catheters to heart due to vascular limitations
- 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)
- Active endocarditis
- History of hemodynamic compromise due to valvular heart disease
- Unstable CAD as determined by the investigator
- Severe proximal three-vessel or left main coronary artery disease without revascularization as determined by the investigator
- History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
- Any other medical condition which may affect the outcome of this study or safety of the subject as determined by the investigator
Sites / Locations
- Royal Adelaide Hospital
- St. Andrew's Hospital
Arms of the Study
Arm 1
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.