Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablatio… (NCT06748157) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation
United States34 participantsStarted 2024-10-02
Plain-language summary
Determine the role of vagal/median nerve stimulation using the CardiaCare RR2 home care wearable neuromodulation system on suppressing atrial arrhythmias and related symptoms in patients who have undergone AF ablation. The study population will be comprised of adults (age ≥18 yrs.) who have undergone AF ablation for paroxysmal or persistent AF.
The study will assess the ability of neuromodulation, using the CardiaCare RR2 home care wearable, to suppress the following:
1. early (0-2 months) post-ablation arrhythmias that occur in the immediate post-ablation time period
2. AF/AT/AFL recurrences between months 2-6 post-ablation.This is a prospective, controlled, double-blind, randomized trial. The first 15 patients will not be randomized and will receive the active median/vagal stimulation only (open label).
The Study will be conducted in up to 1 clinical site in the United States. This study will have 1:1 randomization (active median/vagal stimulation vs sham). The study has been given NSR designation from FDA--NO IDE.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Men and women ages ≥18 years
* Patients planned to undergo or undergoing AF ablation for paroxysmal or persistent AF and able to be randomized within 48 hours of the ablation procedure.
* Ability and willingness to sign an informed consent form.
* Ability and willingness to use CardiaCare RR2 device, continuous ECG monitoring, and has an available SmartPhone.
Exclusion Criteria
* Rheumatic heart disease
* Extensive atrial disease (\* some patients may be determined to be screen failures following the ablation procedure).
* Moderate to severe mitral stenosis or history of mitral valve replacement
* Pacemaker or CRTD or any implanted electrical stimulating device
* Unilateral or bilateral vagotomy
* Peripheral neuropathy affecting the tested upper extremity.
* Severe heart failure (New York Heart Association Class III or IV) within 90 days.
* Recent (within 90 days) stroke or transient ischemic attack.
* Recent (within 90 days) myocardial infarction.
* Pregnancy or breast feeding.
* Life expectancy \<1 year for any medical condition
* Currently enrolled in another study that would interfere with this study
* Unsuitable for participating in the study according to attending physician
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AF/AFL occurrence
Timeframe: at 2-months and 6-months post-ablation procedure