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Electrical Nerve Stimulation
Wearable Device for Electrical Nerve Stimulation for Atrial Fibrillation (STALL-AF Trial)
N/A
Waitlist Available
Led By Peng-Sheng Chen, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic AF.
Symptomatic AF is defined by AF with patient-reported perception of one or more of the following symptoms: palpitations, dizziness/presyncope, syncope, dyspnea, chest pain, malaise, and fatigue and activity intolerance.
Must not have
Heart failure with functional classes III or IV
Recurrent vasovagal syncope
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Summary
This trial will test if a wearable device that sends electrical signals to the body can help improve symptoms in people with atrial fibrillation by better controlling their heart rate.
Who is the study for?
This trial is for adults aged 18-75 with atrial fibrillation (AF) who've had at least one documented AF episode and are symptomatic, experiencing issues like palpitations or dizziness. They must have a left atrial size <50 mm and not responded to an antiarrhythmic drug. Exclusions include severe heart conditions, recent stroke or myocardial infarction, certain syndromes like Wolff Parkinson-White Syndrome, existing neuromodulation devices, allergies to ECG materials, pregnancy, congenital heart diseases, and active thyrotoxicosis.
What is being tested?
The study tests if implanting a device that sends mild electrical signals under the skin can control heart rate in AF patients. Participants will either receive the device with active treatment or without (as a comparison group). The goal is to see if this intervention improves symptoms of AF compared to no electrical stimulation.
What are the potential side effects?
While specific side effects aren't listed for this trial's interventions, potential risks may include discomfort at the implant site, infection risk from surgery for device placement and possible skin irritation from electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience symptoms from atrial fibrillation.
Select...
I experience symptoms like palpitations or dizziness due to my atrial fibrillation.
Select...
My condition did not improve after taking at least one heart rhythm medication.
Select...
My heart's left atrium is smaller than 50 mm.
Select...
I am between 18 and 75 years old.
Select...
I have had episodes of sudden irregular heartbeats that I could feel and have an ECG record of.
Select...
My condition did not improve after taking at least one medication for irregular heartbeat.
Select...
I have had atrial fibrillation lasting more than 30 seconds, confirmed by a week-long heart monitor test within the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart condition severely limits my daily activities.
Select...
I frequently faint due to sudden drops in my heart rate and blood pressure.
Select...
I have a severe heart valve problem.
Select...
I was born with a heart condition.
Select...
I have Wolff-Parkinson-White Syndrome.
Select...
I have not had a stroke in the last 6 months.
Select...
I have had a heart attack before.
Select...
My doctor expects me to live more than a year with my cancer.
Select...
I have had procedures to treat heart rhythm problems or have other serious health issues.
Select...
I have had a type of fast heart rate that lasted more than 30 seconds or was shorter but caused fainting or low blood pressure.
Select...
I have an overactive thyroid.
Select...
I have a heart condition that causes slow heartbeats and symptoms.
Select...
I haven't taken any experimental drugs in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AF Burden
Secondary study objectives
Average SKNA
Quality of Life
Ventricular Rate Control
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental GroupExperimental Treatment1 Intervention
Will receive stimulation ScNS at 3.5mA output
Group II: Control GroupPlacebo Group1 Intervention
Does not receive therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Device Implant with Active Treatment
2021
N/A
~20
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,616 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
1,222 Patients Enrolled for Atrial Fibrillation
Cedars-Sinai Medical CenterLead Sponsor
509 Previous Clinical Trials
162,663 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
430 Patients Enrolled for Atrial Fibrillation
Indiana UniversityOTHER
1,035 Previous Clinical Trials
1,218,963 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
291 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping ability is less than 40%.My heart condition severely limits my daily activities.You have had at least one documented episode of atrial fibrillation (AF) on an electrocardiogram (ECG).I have a heart condition that causes slow heartbeats and symptoms.You have devices in your body that help control nerves, like vagal nerve stimulators or spinal cord stimulators.I experience symptoms like palpitations or dizziness due to my atrial fibrillation.I have had a type of fast heart rate that lasted more than 30 seconds or was shorter but caused fainting or low blood pressure.You have had an allergic reaction to ECG electrodes, adhesive tape, or nylon.Your left atrial size is less than 50 millimeters, as measured by a heart ultrasound.I have had atrial fibrillation lasting more than 30 seconds, confirmed by a week-long heart monitor test within the last 6 months.My heart's left atrium is smaller than 50 mm.I experience symptoms from atrial fibrillation.I am between 18 and 75 years old.I have had a heart attack before.Your heart beats too slowly when measured with an ECG.My condition did not improve after taking at least one heart rhythm medication.I frequently faint due to sudden drops in my heart rate and blood pressure.You did not have any episodes of atrial fibrillation during the monitoring period.I was born with a heart condition.I have Wolff-Parkinson-White Syndrome.Your blood pressure is lower than 90 mm Hg when your heart beats.I have not had a stroke in the last 6 months.I haven't taken any experimental drugs in the last 4 weeks.My doctor expects me to live more than a year with my cancer.I have had procedures to treat heart rhythm problems or have other serious health issues.I have an overactive thyroid.I have had episodes of sudden irregular heartbeats that I could feel and have an ECG record of.My condition did not improve after taking at least one medication for irregular heartbeat.You have a pacemaker or defibrillator implanted in your heart.You have a device called a vagal nerve stimulator.I have a severe heart valve problem.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Group
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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