A Clinical Feasibility Study to Evaluate Patient Perception of MPT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Cardialen, Inc.
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Subject perception of MPT as measured by a pain scale administered immediately following MPT delivery
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
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)
Outcomes
Primary Outcomes
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."?
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."
Secondary Outcomes
- Safety determined from summary report of Adverse Events(Through 30 days post-intervention)