Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation

NCT03593486 | Completed DMC

• 1 other identifier: EMF for Atrial Fibrillation
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Catheter Ablation; Autonomic Imbalance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of pacing attempts required to induce AF

  60 minutes

• AF Cycle length

  60 minutes

• TNF-alpha levels

  60 minutes

Study Arms (2)

Active Stimulation

EXPERIMENTAL

Participants will receive active EMF stimulation through the study device for 60 minutes during the procedure.

Device: Low-level Pulsed EMF

Sham Stimulation

SHAM COMPARATOR

The participant will be positioned in the stimulator, but no EMF stimulation will be delivered.

Device: Sham Stimulation

Interventions

Low-level Pulsed EMF DEVICE

Low-level pulsed electromagnetic field stimulator delivered through a Helmholtz coil positioned around the participant's head and neck. Stimulation parameters are 0.032 µG at 0.89 Hz for 60 minutes.

Active Stimulation

Sham Stimulation DEVICE

The stimulator will be placed around the participant's head and neck, but no EMF will be delivered.

Sham Stimulation

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Health Sciences Center

Oklahoma City, Oklahoma, 73120, United States

Location

Related Publications (5)

• 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. No abstract available.

  PMID: 25912123 BACKGROUND

• 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.

  PMID: 24763467 BACKGROUND

• 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. doi: 10.1097/01.crd.0000094029.10223.2f.

  PMID: 14766023 BACKGROUND

• 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.

  PMID: 25533588 BACKGROUND

• 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.

  PMID: 25744003 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sunny Po, MD, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to either the active or sham stimulation group. Because the parameters are programmed into the stimulator by the manufacturer and given generic names (Stim 1 and Stim 2), the investigators and physicians performing the procedure will not know which protocol is active or sham.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 20, 2018
• Study Start: September 27, 2018
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)