Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation

ID#: NCT06748157

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 02, 2024

End Date: April 01, 2025

Contact Information:
Stephanie Harcum, MS
347 852 0190
Betsy Ellsworth, MS
347 498 3855
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.
Eligibility: 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
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