No phaseActive, not recruiting

The Effect of Low-Level Tragus Stimulation on Inflammation and Early Recurrence After Pulsed Field Ablation: A Randomized Controlled Study

Sponsor
Xi'an Jiaotong University (Academic or other)
Enrollment
46 planned
Conditions
Atrial Fibrillation
Interventions
Low-Level Tragus Stimulation; Sham Low-Level Tragus Stimulation
Ages
adults, older adults
Registry
NCT07633431

Full record on ClinicalTrials.gov

From the registry

Atrial fibrillation is a common heart rhythm disorder. Some patients may have early episodes of atrial arrhythmia after pulsed field ablation, and inflammation after the procedure may be related to these early episodes. Low-level tragus stimulation is a non-invasive form of nerve stimulation applied to the outer ear. It may help regulate the autonomic nervous system and inflammatory responses. This randomized controlled study will evaluate whether low-level tragus stimulation after pulsed field ablation can reduce post-procedural inflammation and early atrial arrhythmia recurrence in patients with atrial fibrillation. Participants who meet the study criteria will be randomly assigned to receive either active low-level tragus stimulation or sham stimulation after the ablation procedure. The study will compare inflammatory markers before and after the procedure, monitor heart rhythm during and after the stimulation period, and assess early atrial arrhythmia recurrence during follow-up. The investigators hypothesize that low-level tragus stimulation may reduce inflammatory responses…

Primary outcomes

  • Change in Serum Inflammatory Marker Levels From Baseline to 24 Hours After Pulsed Field Ablation

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered