Atrial Fibrillation Clinical Trial
Official title:
Effect of Low-Level Electromagnetic Field Stimulation on Patients With Paroxysmal Atrial Fibrillation
Verified date | December 2019 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 26, 2019 |
Est. primary completion date | November 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Adult patients aged 21-85 presenting for ablation of paroxysmal atrial fibrillation (episodes of atrial fibrillation lasting < 7 days with or without prior cardioversion) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | OU Health Sciences Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Chen PS, Chen LS, Fishbein MC, Lin SF, Nattel S. Role of the autonomic nervous system in atrial fibrillation: pathophysiology and therapy. Circ Res. 2014 Apr 25;114(9):1500-15. doi: 10.1161/CIRCRESAHA.114.303772. Review. — View Citation
Scherlag BJ, Yamanashi WS, Hou Y, Jacobson JI, Jackman WM, Lazzara R. Magnetism and cardiac arrhythmias. Cardiol Rev. 2004 Mar-Apr;12(2):85-96. — View Citation
Stavrakis S, Humphrey MB, Scherlag BJ, Hu Y, Jackman WM, Nakagawa H, Lockwood D, Lazzara R, Po SS. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol. 2015 Mar 10;65(9):867-75. doi: 10.1016/j.jacc.2014.12.026. — View Citation
Wang S, Zhou X, Wang Z, Huang B, Zhou L, Chen M, Yu L, Jiang H. Magnetic fields in noninvasive heart stimulation: A novel approach for anti-atrial fibrillation. Int J Cardiol. 2015;190:54-5. doi: 10.1016/j.ijcard.2015.04.155. Epub 2015 Apr 21. Review. — View Citation
Yu L, Dyer JW, Scherlag BJ, Stavrakis S, Sha Y, Sheng X, Garabelli P, Jacobson J, Po SS. The use of low-level electromagnetic fields to suppress atrial fibrillation. Heart Rhythm. 2015 Apr;12(4):809-17. doi: 10.1016/j.hrthm.2014.12.022. Epub 2014 Dec 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in duration of pacing-induced atrial fibrillation | Change in the duration of atrial fibrillation that is induced by burst-pacing compared between the two groups before and after the stimulation period. | 60 minutes | |
Secondary | Number of pacing attempts required to induce AF | Number of burst-pacing attempts that are required to successfully induced atrial fibrillation, compared between the two groups before and after the stimulation period. | 60 minutes | |
Secondary | AF Cycle length | Cycle length of induced atrial fibrillation, compared between the two groups before and after the stimulation period. | 60 minutes | |
Secondary | TNF-alpha levels | Levels of the inflammatory mediator TNF-alpha measured in central venous blood, compared between the two groups before and after the stimulation period. | 60 minutes |
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