Cardioneural Temporary Pacing to Achieve Autonomic Modulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

Atrial fibrillation (AF) is the most common arrhythmia, with a lifetime risk of 1 in 3-5. In cases of rapid ventricular rate, patients often experience low blood pressure, making standard rate and rhythm control medications contraindicated. While cardioversion may be necessary, it is often ineffective in long-standing AF and can lead to left ventricular stunning. This creates a vicious cycle, worsening heart failure and cardiogenic shock.

AV node ablation may be required, but it is irreversible and carries risks, including complications from long-term pacing. Therefore, temporary pacing may be a preferable option to allow for hemodynamic improvement and better ventricular filling.

Research suggests that parasympathetic fibers innervating the AV node can modulate conduction. Ablation in these fibers has shown promise for treating vagal-mediated syncope, and high-frequency pacing may provide chronic heart rate suppression. Intermittent pacing has also been effective in reducing ventricular rates in atrial fibrillation to prevent inappropriate ICD shock. This may be potentially beneficial for patients with uncontrolled fast AF.

In a proof-of-concept study with five patients, pacing at 30Hz and 10mA in the coronary sinus resulted in a dose-dependent prolongation of the ventricular cycle length during AF, with stable blood pressure and no discomfort reported. This suggests that pacing these fibers could achieve rate control without the need for medications or AV node ablation, with no complications observed.

This study aims to evaluate safety and efficacy of temporary cardio-neural pacing (CNP). This is a prospective cohort study involving patients with atrial fibrillation (AF) and rapid ventricular conduction who have failed or are contraindicated for rate control with antiarrhythmic medications. Enrolled patients will be followed up for 1 month.

Eligibility criteria

Qualifiers

Patients with atrial fibrillation or atrial flutter who are having rapid ventricular rate >100bpm

Patient who cannot take rate control agents, or heart rate control remains unsatisfactory after rate control agents

Disqualifiers

Patients who cannot provide informed consent

Patients < 18 years old

Pregnant patients

Illiterate patients

Trial design

Treatments tested in this trial

  • Temporary cardio-neural pacing

Treatment groups

33 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Prince of Wales Hospital Status unavailable Hong Kong, Sha TinHong KongHong Kong