- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03593486
Low-Level EMF Stimulation for Paroxysmal Atrial Fibrillation
Effect of Low-Level Electromagnetic Field Stimulation on Patients With Paroxysmal Atrial Fibrillation
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This is a prospective, randomized, sham-controlled trial. Patients will be enrolled upon presentation to our electrophysiology (EP) lab for ablation of paroxysmal AF. After informed consent is obtained, the patient will be randomized to one of two protocols that have been pre-programmed into the magnetic field stimulator. As described below, one of the protocols will be an active stimulation protocol, and one will be sham (i.e. no stimulation delivered). These will be named "Stim 1" and "Stim 2" in the computer. Because the specifics of the protocol are programmed into the stimulator by the device manufacturer, investigators will not know which of these two protocols is active vs. sham. The patient will then be brought to the EP lab for the procedure and will be placed on the lab table with their head positioned in the magnetic coil. Vascular access will then be obtained and diagnostic catheters placed as is standard practice for AF ablation.
Because the study is limited to patients with paroxysmal AF, patients will begin the study in normal sinus rhythm (NSR). Before the experimental protocol is begun, baseline electrophysiologic intervals will be recorded as is standard practice for all patients presenting for EP study. This will include measurement of the atrio-ventricular nodal effective refractory period (AVNERP) using programmed stimulation from the right atrial (RA) appendage, atrio-his (AH) interval, and his-ventricular (HV) interval per standard practice. Burst atrial pacing will then be utilized to induce AF. Measurements of the number of burst pacing attempts required to induce AF, as well as the AF cycle length, and duration of pacing-induced AF will be recorded. Attempts at AF induction will occur for 15 minutes. Prior to induction of AF, 5ml of venous blood will be drawn from the central venous sheaths to measure baseline levels of the inflammatory mediator (TNF)-α. These samples will be stored for analysis.
After baseline measurements are obtained, the coil will be turned on and whichever protocol the patient has been assigned to will be run. The system to be used contains a signal-generator coupled to a Helmholtz coil capable of producing a magnetic field in response to an electric current. The Helmholtz coil itself is has 9 inches of separation in between the two coils that allows for placement of the coil around the participant's head and upper neck. The choice of the head and neck as the site of stimulation is intended to target the vagus nerve as it exits the jugular foramen to course caudally in the carotid sheath. The system is designed to create a homogenous, isotropic magnetic field with a field strength from 1 to 99 pico-Tesla (pT) with a frequency range of 0.01 Hz to 50 Hz.
Active Stimulation will involve application of a pulsed-EMF with the parameters 0.032 micro-gauss (µG) at 0.89 Hz for 60 minutes. In participants randomized to sham stimulation, the coil will be positioned around the neck as previously described, but no current will be applied to the stimulator.
During the 60 minute stimulation time, trans-septal puncture and mapping of the left atrium will be performed as is standard practice for this procedure, but no ablation will be performed. After the 60 minute protocol is complete, venous blood samples will again be drawn (within 5 minutes of protocol completion), stored, and analyzed as previously described. If the patient remains in AF after the end of the 60 minute session, they will be electrically cardioverted to sinus rhythm. The same stimulation protocol as described previously will again be employed, again noting number of attempts required to induce AF, duration of pacing-induced AF, AF cycle length, and measurements of AVNERP, AH, HV intervals and levels of TNF-α.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73120
- OU Health Sciences Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Active Stimulation
Participants will receive active EMF stimulation through the study device for 60 minutes during the procedure.
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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.
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Falešný srovnávač: Sham Stimulation
The participant will be positioned in the stimulator, but no EMF stimulation will be delivered.
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The stimulator will be placed around the participant's head and neck, but no EMF will be delivered.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in duration of pacing-induced atrial fibrillation
Časové okno: 60 minutes
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Change in the duration of atrial fibrillation that is induced by burst-pacing compared between the two groups before and after the stimulation period.
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60 minutes
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of pacing attempts required to induce AF
Časové okno: 60 minutes
|
Number of burst-pacing attempts that are required to successfully induced atrial fibrillation, compared between the two groups before and after the stimulation period.
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60 minutes
|
AF Cycle length
Časové okno: 60 minutes
|
Cycle length of induced atrial fibrillation, compared between the two groups before and after the stimulation period.
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60 minutes
|
TNF-alpha levels
Časové okno: 60 minutes
|
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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Sunny Po, MD, PhD, University of Oklahoma
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EMF for Atrial Fibrillation
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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