Assess the subject acceptance of MPT, using therapy parameters that have been shown to be effective in terminating episodes of atrial fibrillation.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
Electrical Stimulation
Royal Adelaide Hospital
Adelaide, South Australia, Australia
St. Andrew's Hospital
Adelaide, South Australia, Australia
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."
Time frame: 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."?
Time frame: Immediately following MPT delivery
Safety determined from summary report of Adverse Events
Adverse Event frequency by Adverse Event type
Time frame: Through 30 days post-intervention
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