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Nerve Stimulation Therapy for Atrial Fibrillation
N/A
Waitlist Available
Research Sponsored by Cala Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial studies reducing AF burden with nerve stimulation, using wrist/ear devices & ECG patch, plus wrist-worn monitor to track HR/HRV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of time spent in AF during the 4-week treatment period compared to the 2-week run-in period (prior to treatment) for AF episodes >= 30 seconds duration
Secondary outcome measures
Atrial Fibrillation Effect on Quality of Life (AFEQL) score at the end of the treatment period compared to end of the run-in period
Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration)
Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions
+5 moreOther outcome measures
Number of AF-related emergency visits
Number of AF-related in-patient hospitalizations
Number of cardioversion procedures
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Wrist DeviceActive Control1 Intervention
Twice daily stimulation sessions during the 4-week treatment period
Group II: Ear DeviceActive Control1 Intervention
Twice daily stimulation sessions during the 4-week treatment period
Group III: Sham DevicePlacebo Group1 Intervention
Twice daily "stimulation" sessions during the 4-week treatment period
Find a Location
Who is running the clinical trial?
Cala Health, Inc.Lead Sponsor
8 Previous Clinical Trials
828 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had seizures or epilepsy in the past.You had a cardioversion procedure in the past 12 weeks.You have a specific type of irregular heartbeat that has been confirmed by a heart ultrasound.Your heart's pumping ability is less than 35%.You have experienced repeated fainting episodes related to a sudden drop in heart rate and blood pressure.You have had surgery to cut the vagus nerve.Unstable blood pressure or heart rate.You have nerve damage in your left arm.You have severe heart failure.Your heart's left atrial anteroposterior diameter is larger than 5.5 cm when checked with a special heart ultrasound.You have had or are planning to have a heart transplant or heart surgery.You had a stroke or mini-stroke in the last 6 months.You had a heart attack in the past 6 months.You have been diagnosed with a specific type of irregular heart rhythm, which can be confirmed by different heart monitoring tests.You have a device like a pacemaker or defibrillator implanted in your body.You have experienced symptoms of atrial fibrillation at least once a month for the past three months.You have a heart condition that affects its structure.You must be between 22 and 80 years old.You have had atrial fibrillation for at least 5% of the time in the past 3 months, and your treatment for atrial fibrillation has not changed since then.You have metal or electrical devices in your head or treated hand.
Research Study Groups:
This trial has the following groups:- Group 1: Wrist Device
- Group 2: Ear Device
- Group 3: Sham Device
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.
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT05653583 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial include persons aged seventy-five and above?
"Eligible participants must be between 22 and 79 years old."
Answered by AI
Are there openings currently available for individuals to join this trial?
"The clinical trial registry shows that this medical experiment is not currently open to new participants, as the last update was on December 14th 2022. Despite its closure, there are still 480 other studies actively recruiting patients at present."
Answered by AI
Who meets the qualifications for participation in this medical study?
"This trial seeks 30 individuals with atrial fibrillation, aged between 22 and 79. To be considered for the study, applicants must have a 5% AF burden within 3 months prior to enrollment, no recent changes in medication treatment, smartphone access to download associated applications, written informed consent of participation, paroxysmal atrial fibrillation documented on ECG/TTM/monitoring/recording (episodes >30 seconds), and one symptomatic episode per month over the last quarter."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am hoping that this non invasive procedure helps to control my condition. Perhaps reduce drug use and having another ablation.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What is the screening process and time frame?
PatientReceived 1 prior treatment
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