Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation
Completed · Not applicable · Has a placebo group
Conditions studied: Atrial Fibrillation, Catheter Ablation, Autonomic Imbalance
In brief
This research has two main specific aims. First, a commercially-available stimulator will be utilized to assess the effect of low-level electromagnetic field (EMF) stimulation on atrial fibrillation (AF) inducibility in patients with paroxysmal AF presenting for catheter ablation as compared to sham stimulation. We hypothesize a reduction in AF inducibility in patients treated with EMF stimulation. Second, we aim to assess for the effect of low-level EMF on level of systemic inflammatory mediators. We hypothesize a reduction in the level of the inflammatory mediator tissue necrosis factor (TNF)-α in patients treated with EMF stimulation as compared to sham stimulation. The long-term objective of this research is to develop low-level EMF as a therapeutic alternative for patients with AF, and this research will help to determine the efficacy of low-level pulsed EMF in this regard.
Key facts
- Study ID
- NCT03593486
- Run by
- University of Oklahoma
- People needed
- 18
- Starts
- 2018-09-27
- Expected to finish
- 2019-11-26
- Last updated by the study team
- 2019-12-20
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients aged 21-85 presenting for ablation of paroxysmal atrial fibrillation (episodes of atrial fibrillation lasting < 7 days with or without prior cardioversion)
You may not qualify if…
- Left ventricular ejection fraction (LVEF) < 40%
- Stroke or myocardial infarction within the past 6 months
- Greater than moderate valvular stenosis or regurgitation as assessed by pre-procedure transthoracic echocardiogram (TTE)
- Presence of a prosthetic heart valve.
Where it is running
- OU Health Sciences Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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