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Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation (TREAT-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02548754
Recruitment Status : Active, not recruiting
First Posted : September 14, 2015
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Inflammation Device: Parasym device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRanscutaneous Electrical vAgus Nerve sTimulation to Suppress Atrial Fibrillation
Study Start Date : May 2016
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Patients will receive 1 hour of active low level tragus stimulation daily for 6 months
Device: Parasym device
Sham Comparator: Sham
Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months
Device: Parasym device



Primary Outcome Measures :
  1. Atrial fibrillation burden [ Time Frame: 6 months ]
    Percent time spent in atrial fibrillation


Secondary Outcome Measures :
  1. Markers of inflammation [ Time Frame: 6 months ]
    Serum levels of tumor necrosis factor-alpha

  2. Markers of inflammation [ Time Frame: 6 months ]
    Serum levels of inteleukin 6

  3. Markers of inflammation [ Time Frame: 6 months ]
    Serum levels of C-reactive protein



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients older than 21 year old
  2. Paroxysmal AF

Exclusion Criteria:

  1. Left ventricular dysfunction (Left ventricular ejection fraction <40%)
  2. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
  3. Recent (<6 months) stroke or myocardial infarction
  4. Severe heart failure (NYHA IV)
  5. Left atrial dilatation (>55mm)
  6. Recurrent vaso-vagal syncopal episodes
  7. Unilateral or bilateral vagotomy
  8. Pregnancy or breast feeding
  9. Sick sinus syndrome, 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms) 1st degree AV block.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548754


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
American Heart Association
Investigators
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Principal Investigator: Stavros Stavrakis, MD University of Oklahoma

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT02548754    
Other Study ID Numbers: RSRCH135160
15MCPRP25790001 ( Other Grant/Funding Number: American Heart Association )
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Keywords provided by University of Oklahoma:
atrial fibrillation
neuromodulation
inflammation
Additional relevant MeSH terms:
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Atrial Fibrillation
Inflammation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes