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NCT Number: NCT07247422

Cardioneural Temporary Pacing to Achieve Autonomic Modulation

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.

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Key information

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

During 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, such as when the heart rate stabilized. Cardioneural pacing will be performed at lowest output at a frequency of 5-50Hz via the atrial lead (CNP lead). The ventricular lead will have pacing mode being set at 80bpm VVI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Heart Rate equal or lower than 80bpm

    Time frame: In implant procedure

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

Secondary outcomes

  1. Threshold

    Time frame: In implant procedure

    Pacing threshold to achieve HR<=80 with CNP.

  2. Patient discomfort

    Time frame: In implant procedure

    Number of patients with discomfort from patient during CNP

  3. Mean blood pressure

    Time frame: In implant procedure

    Mean blood pressure during CNP, compared with that before pacing.

  4. Blood Biochemistry

    Time frame: In implant procedure

    Change of blood biochemistry including lactate level and pH in blood gas.

  5. Inotrope dosage

    Time frame: In implant procedure

    Determine Inotrope dosage

Study contacts

Contact information is provided by the study sponsor or research team.

Tsz Kin Tam

CONTACT

[email protected]

852 35051750

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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