NCT06748157Active, not recruiting
Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 19 Dec 2024
- Start date
- 2 Oct 2024
- Primary completion date
- 14 Aug 2026
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Atrial fibrillation
- NCT number
- NCT06748157
What you commit to
- Study type: Interventional
- Participants enrolled: 51
- From 2 Oct 2024 to the primary completion date, 14 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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.
- Life expectancy \<1 year for any medical condition
Other
- Pacemaker or CRTD or any implanted electrical stimulating device
- Unilateral or bilateral vagotomy
- Peripheral neuropathy affecting the tested upper extremity.
- Pregnancy or breast feeding.
- Currently enrolled in another study that would interfere with this study
- Unsuitable for participating in the study according to attending physician
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.