Cardioneural Temporary Pacing to Achieve Autonomic Modulation

NCT07247422 | Not Yet Recruiting

• 1 other identifier: Temp CNP Study
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporary Cardio-neural Pacing; Pacemaker Implantation

Keywords

cardio-neural pacing

Outcome Measures

Primary Outcomes (1)

• Heart Rate equal or lower than 80bpm

  Number of patients achieving \<=80bpm heart rate with cardio-neural pacing

  In implant procedure

Secondary Outcomes (5)

• Threshold

  In implant procedure

• Patient discomfort

  In implant procedure

• Mean blood pressure

  In implant procedure

• Blood Biochemistry

  In implant procedure

• Inotrope dosage

  In implant procedure

Study Arms (1)

temporary cardio-neural pacing

EXPERIMENTAL

Patient will undergo temporary cardio-neural pacing in study procedure

Procedure: Temporary cardio-neural pacing

Interventions

Temporary cardio-neural pacing PROCEDURE

Arterial line will be inserted for monitoring of blood pressure. A temporary ventricular lead will be first implanted, potentially to the left bundle area to preserve normal conduction physiology. A coronary sinus sheath (attain command or deflectable) will be delivered to RA septum, posterior to CS ostium, at the expected location of parasympathetic ganglion plexus. Pace mapping will be performed with a pacing lead (such as Select Secure 3830) at 30Hz. An electrophysiology catheter may be used where necessary for pace-mapping the response. At the site where lowest output can generate 30% prolongation of ventricular CL, the lead is fixed for 1-5mm depth. The output is tested again to achieve heart rate slowing to less than 80bpm. Fluoroscopic image will be collected with contrast injection at the sheath. Eventually, the implanted lead will be connected into a temporary pacemaker. The temporary leads will be removed when no longer clinically required.

temporary cardio-neural pacing

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who cannot provide informed consent
• Patients \< 18 years old
• Pregnant patients
• Illiterate patients

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Sha Tin, Hong Kong

Location

Central Study Contacts

Tsz Kin Tam

CONTACT

852 35051750; marktam@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

HK (1)