CLINICAL TRIAL

active tVNS for Atrial Fibrillation

High Risk
Refractory
Recruiting · 18+ · All Sexes · Los Angeles, CA

This study is evaluating whether a non-invasive stimulation of the vagus nerve may help reduce the risk of atrial fibrillation after cardiac surgery.

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About the trial for Atrial Fibrillation

Treatment Groups

This trial involves 2 different treatments. Active TVNS is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
active tVNS
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
sham tVNS
DEVICE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
active tVNS
2019
N/A
~20

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient's sinus rhythm is normal at its baseline. show original
is mandatory In order to participate in the study, you must provide written consent stating that you are aware of the risks and benefits of participating and that you agree to comply with all study procedures for the duration of the study. show original
People who are scheduled to undergo a coronary artery bypass surgery, a major vascular/aneurysm repair, a valve replacement or repair, or both, for a clinically indicated reason. show original
Must be ≥ 18 years old. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Within 12 hours of arrival to the ICU after surgery and on postop day 3 (2 days)
Screening: ~3 weeks
Treatment: Varies
Reporting: Within 12 hours of arrival to the ICU after surgery and on postop day 3 (2 days)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Within 12 hours of arrival to the ICU after surgery and on postop day 3 (2 days).
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether active tVNS will improve 1 primary outcome and 7 secondary outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of Postop day 0 until discharge from the hospital, an average of 1 week..

Days of hospitalization
POSTOP DAY 0 UNTIL DISCHARGE FROM THE HOSPITAL, AN AVERAGE OF 1 WEEK.
Number of days in the hospital from postoperative day 0 to discharge.
POSTOP DAY 0 UNTIL DISCHARGE FROM THE HOSPITAL, AN AVERAGE OF 1 WEEK.
Pain assessment
6 DAYS
Pain scores will be assessed on postoperative days 0-5 using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded into the medical record by the nurse monitoring the subject as part of standard care. Postop day 0 is the day of the surgery and is the first day of the time frame and postoperative day 5 is the 6th day.
6 DAYS
Duration of post-op atrial fibrillation
6 DAYS
How many hours or days for each incidence of postoperative atrial fibrillation for postoperative days 0-5 (postop day 0 is the day of the surgery and is the first day of the time frame and postoperative day 5 is the 6th day).
6 DAYS
Atrial Fibrillation
6 DAYS
Incidence of post-operative atrial fibrillation for postoperative day 0-5 (postop day 0 is the day of the surgery and is the first day of the time frame and postoperative day 5 is the 6th day).
6 DAYS
Heart rate during atrial fibrillation
6 DAYS
The heart rate during each incidence of postoperative atrial fibrillation for postop days 0-5 (postop day 0 is the day of the surgery and is the first day of the time frame and postoperative day 5 is the 6th day).
6 DAYS
Narcotic Usage
6 DAYS
Total narcotic consumption will be calculated each day for postoperative days 0-5. Narcotic amount will be converted to a standard unit equivalent for comparison. Postop day 0 is the day of the surgery and is the first day of the time frame and postoperative day 5 is the 6th day.
6 DAYS
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Who is running the study

Principal Investigator
J. K. H.
Prof. Jonathan K. Ho, Associate Clinical Professor
University of California, Los Angeles

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for atrial fibrillation?

In a sample of patients hospitalized for AF, common treatments for AF were ACEI use (70%), beta blocker use (51%), NSAIDS (49%), diuretics (36%) and amiodarone (34%).

Anonymous Patient Answer

How many people get atrial fibrillation a year in the United States?

The risk of AF appears to be higher in a minority of people. Among those with AF in a given year, about 6.3 million persons are hospitalized and 16.1 million receive ambulatory care for AF.

Anonymous Patient Answer

Can atrial fibrillation be cured?

After the maze procedure the majority of patients have no recurrence or symptomatic AF but require antiarrhythmic medications. Long-term survival rates after maze operation are comparable to results published in the literature in the mid-1980s, however, more than two thirds of these patients will need antiarrhythmic medications (e.g. beta-adrenergic blockers).

Anonymous Patient Answer

What is atrial fibrillation?

The terms “atrial fibrillation” or “atrium fibrilation” can be traced back to the Hippocratic Corpus. Hippocrates wrote about a turbulent (vibratory) disease of the heart, also called “fibril”, which may date back as far as 1500 BC.\nAtrial fibrillation is the most common form of non paroxysmal atrial tachycardia (NPAT).NPAT is defined as a rapid, irregular, and irregularly in rhythm (irregularity) of the atria and is caused by an imbalance between atrial contraction and the sinus rhythm.

Anonymous Patient Answer

What are the signs of atrial fibrillation?

Atrial fibrillation is not always a benign condition but can lead to increased risk for heart attacks, stroke, or heart failure. The signs of atrial fibrillation are variable and can take various forms, such as rheumatic heart disease, the effect of anaesthesia on atrial fibrillation, and the presence of valvular heart disease.

Anonymous Patient Answer

What causes atrial fibrillation?

The most common cause of paroxysmal and persistent AF is atrial myocarditis while hypertrophic cardiomyopathy is associated with paroxysmal persistent AF. The pathogenic pathways leading to AF can also be affected by genetic and autoimmune conditions. Clinical Trial Registration Identifier: www.isrctn.org, ISRCTN72218498.

Anonymous Patient Answer

What are the common side effects of active tvns?

Symptoms of atrial fibrillation, such as palpitations, occurred at the start of all the treatments and most patients also had anxiety and mood disturbance. Side effects in patients with atrial fibrillation in our study ranged considerably from mild to severe and included dizziness, nausea, vomiting, weakness, chest pain, headache, feeling warm or numbness; fatigue in women or shortness of breath, shortness of breath and chest pain in men. The symptoms of atrial fibrillation in some people often do not resolve to date even after treatment with active medication. In such cases, further evaluation and management is indicated.

Anonymous Patient Answer

What does active tvns usually treat?

There are no randomized clinical trials to back up these treatments. What we do have are the observations of our clinicians which have demonstrated, in general, that the treatments that have been shown helpful in the past will work as well in the present. So, active television and active music (i.e. listening to your music) will work when used as a part of your active treatment plan for atrial fibrillation. We think the most important thing is for you to keep your heart healthy and proactive to manage your other health problems. Take proactive medications as recommended and do your utmost to abstain from tobacco, soaps, and alcoholic beverages. If you can't, then see your doctor and learn the benefits of nicotine replacement therapy.

Anonymous Patient Answer

Does active tvns improve quality of life for those with atrial fibrillation?

We did not show that active surveillance had any significant positive effect on HRQL in patients with the condition. However, patients reported poorer functioning due to AF-related symptoms, irrespective of the activity group.

Anonymous Patient Answer

How serious can atrial fibrillation be?

Atrial Fibrillations is a serious health concern because of the consequences that can arise if they are not treated properly as they may result in a number of serious complications if left untreated. The symptoms that arise, however, depend upon the type of AF that is currently present.

Anonymous Patient Answer

Does atrial fibrillation run in families?

Atrial fibrillation is familial in approximately 1 in 3000 patients. We have demonstrated that a gene defect in the fibromodulin-BMP-8 gene-expressing tissue, the so-called fibromodulin-BMP-8 gene, is a possible candidate. In conjunction with the previous studies on AF.

Anonymous Patient Answer

What is active tvns?

Inappropriate activity levels can be a serious and sometimes fatal side effect of certain antiarrhythmic medications and the identification of these medications needs to be remembered. Those taking atrial beta blockers or antihistamines should be aware of the potential for excessive sedation at night. I would therefore urge clinicians to ask their patients what their activities are like particularly during the night.

Anonymous Patient Answer
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