Parasym Stimulation for Atrial Fibrillation
(SNAP-GP Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Oklahoma

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests whether mild electrical pulses to the ear can help patients with atrial fibrillation by affecting heart neurons that control rhythm. The study focuses on patients undergoing heart surgery and aims to see if this method can change neuron activity to reduce abnormal heartbeats. This technique has been shown to significantly reduce atrial fibrillation in previous studies.

Research Team

Eligibility Criteria

This trial is for men and women over 21 years old who are scheduled for open heart surgery. It's not suitable for those needing emergency heart surgery.

Inclusion Criteria

I am over 21 years old.

I am scheduled for open heart surgery.

Exclusion Criteria

I am having emergency open heart surgery.

Treatment Details

Interventions

Low level tragus stimulation (LLTS) (Behavioural Intervention)

Trial OverviewThe study tests if low level tragus stimulation (LLTS) affects nerve connections in the heart, which might influence atrial fibrillation. Participants will be randomly assigned to receive LLTS or no stimulation during their surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active stimulationExperimental Treatment1 Intervention

Patients undergoing cardiac surgery will be randomized to active low level tragus stimulation for 30 min (pulse width of 200 μs, amplitude of 20 mA and a pulse frequency of 20 Hz). Stimulation will be provided using the Parasym device.

Group II: Sham stimulationPlacebo Group1 Intervention

Patients undergoing cardiac surgery will be randomized to sham stimulation for 30 min. The Parasym device will be placed on the patient's tragus, but no current will be delivered.