An interventional study of Parasym device in Atrial Fibrillation and Inflammation, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
Atrial fibrillation (AF) is the most common cardiac arrhythmia. In previous experimental studies, the investigators found that low-level vagus nerve (VN) stimulation (LLVNS), at voltages substantially below that which slowed the sinus rate, significantly suppressed AF inducibility and decreased AF duration. The investigators subsequently developed a non-invasive neuromodulatory therapy, in which LLVNS was delivered to the auricular branch of the VN located at the tragus, the anterior protuberance of the outer canine ear (low level tragus stimulation; LLTS). The anti-arrhythmic effects of LLTS were similar to those of LLVNS delivered to the cervical VN trunk. More recently, in a proof-of-concept study in humans, the investigators showed that in patients with drug-refractory AF undergoing AF ablation, LLTS for just one hour significantly shortened the AF duration and decreased inflammatory cytokines.
The overall objective of this proposal is to translate in ambulatory patients with paroxysmal AF the results of previous studies showing acute suppression of AF and inflammation in anesthetized canines as well as humans, in order to examine the long-term therapeutic effects of this approach. The investigators hypothesize that intermittent (1 hour daily) LLTS for 6 months may result in long-term decrease of AF burden and suppression inflammatory cytokines in patients with paroxysmal AF. Patients will be randomized to either active or sham LLTS. LLTS will be delivered through a transcutaneous electrical nerve stimulation (TENS) device for 1 hour daily over a 6-month period. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous ECG monitoring at baseline and at 6 months. In addition, blood samples will be collected from patients at baseline, and at 3 and 6 months, for cytokine measurement. These investigations will establish the first evidence of the long-term effects of LLTS on AF suppression in patients with paroxysmal AF and may provide the basis for a potential expansion of the therapeutic targets of this treatment modality beyond AF.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 53 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
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Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Exclusion Criteria:
Patients will receive 1 hour of active low level tragus stimulation daily for 6 months
Device: Parasym device
Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months
Device: Parasym device
Atrial Fibrillation Burden
Percent time spent in atrial fibrillation
Time frame: 6 months
Markers of Inflammation
Serum levels of tumor necrosis factor-alpha
Time frame: 6 months
Markers of Inflammation
Serum levels of inteleukin 6
Time frame: 6 months
| Milestone | Active | Sham |
|---|---|---|
| Started | 26 | 27 |
| Completed | 24 | 23 |
| Not completed | 2 | 4 |
Percent time spent in atrial fibrillation
| Percent time spent in atrial fibrillatio | Active | Sham |
|---|---|---|
| Atrial Fibrillation Burden | 2 (0 to 11) | 8.5 (0 to 42) |
Serum levels of tumor necrosis factor-alpha
| pg/ml | Active | Sham |
|---|---|---|
| Markers of Inflammation | 5.5 (3.9 to 8.3) | 5.4 (4.4 to 8.3) |
Serum levels of inteleukin 6
| pg/ml | Active | Sham |
|---|---|---|
| Markers of Inflammation | 1.5 (0.7 to 3.2) | 2.3 (1 to 4.4) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 1/26 (3.8%) | 0/26 (0%) | 0/26 (0%) |
| Sham | 2/27 (7.4%) | 0/27 (0%) | 0/27 (0%) |
| Age, Continuous(years) | Active | Sham | Total |
|---|---|---|---|
| Mean | 65 ± 15 | 68 ± 11 | 67 ± 12 |
| Sex: Female, Male(Participants) | Active | Sham | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 12 | 12 | 24 |
| Race (NIH/OMB)(Participants) | Active | Sham | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 25 | 24 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| AF burden(%) | Active | Sham | Total |
|---|---|---|---|
| Median | 4.5 (0.2 to 31) | 1 (0 to 15) | 2.5 (0.2 to 21) |
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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