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NCT Number: NCT07007000

Cardio-neural Pacing to Modulate AV Conduction in Persistent AF Patients - a Feasibility Study

Atrial fibrillation is the commonest arrhythmia with a lifetime risk of one in 3-5. In patients with late stage of persistent atrial fibrillation, rate control is usually preferred over rhythm control. Besides medication therapy, atrioventricular nodal ablation is sometimes required with placement of a pacemaker afterwards.

The AV node is being innervated by parasympathetic fibres that modulate its conduction. Ablation in these parasympathetic innervations around the coronary sinus (at the CS ostium or posterior to it) has been shown to be promising for treating vagal mediated syncope. Stimulation of these fibres with high frequency pacing could achieve chronic heart rate suppression in animal model. Intermittent pacing in this area has also been shown to be successful in reducing ventricular rate in atrial fibrillation to prevent inappropriate ICD shock.

As a proof-of-concept case, we attempted pacing cardio-neural fibres in one of our patients. Pacing 30Hz at 10mA, 2ms pacing in ostial or postero-septal coronary sinus both resulted in a dose dependent prolongation of VV cycle length during atrial fibrillation. Patient did not complain of discomfort during such pacing. We postulate that pacing these fibers can achieve rate control and avoid the need for rate control medication or AV node ablation in some of these patients.

This study aims to evaluate safety and efficacy of temporary cardio-neural pacing (CNP), and collect fluoroscopic images and electroanatomical mapping data on cardio-neural pacing sites.

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Key information

Conditions

Cardio-neural Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a prospective cohort study. 10 patients with persistent atrial fibrillation with pacing indication will be recruited. They are all scheduled to undergo permanent transvenous pacemakers according to clinical need. Informed consent will be signed before procedure. Arterial line will be inserted for monitoring of blood pressure. After routine ventricular lead implantation, 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, variable amplitude (20, 10, 5V) at 1ms pulse width. 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 2-5mm depth. The output is tested again to achieve 50% prolongation of ventricular CL (at 20, 10, 5, 2, 1V). Fluoroscopic image will be collected with contrast injection at the sheath. Repositioning of lead can be performed if the rate suppression cannot be achieved with [email protected]. Eventually, the implanted lead will serve as an atrial sensing and pacing lead and will not be removed at the end of procedure. Patient will be connected to a dual chamber pacemaker with device programming per usual clinical care. Patients will be followed up for 3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with persistent atrial fibrillation who are scheduled for pacemaker implantation per guideline indication

Exclusion criteria

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

Treatment and study plan

Temporary cardio-neural pacing

Device

After routine ventricular lead implantation, a coronary sinus sheath 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 at 30Hz, variable amplitude (20, 10, 5V) at 1ms pulse width. 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 2-5mm depth. The output is tested again to achieve 50% prolongation of ventricular CL (at 20, 10, 5, 2, 1V). Fluoroscopic image will be collected with contrast injection at the sheath. Repositioning of lead can be performed if the rate suppression cannot be achieved with [email protected]. Implanted lead will serve as an atrial sensing and pacing lead and will not be removed at the end of procedure. Patient will be connected to a dual to a dual chamber pacemaker with device programming per usual clinical care.

Primary outcomes

  1. Percentage prolongation of CL

    Time frame: In implant procedure

    Measure percentage prolongation of CL with lead fixation

Secondary outcomes

  1. Threshold

    Time frame: In implant procedure

    Determine the lowest threshold to achieve prolongation

  2. Discomfort

    Time frame: In implant procedure

    Any discomfort from patient during cardio-neural pacing

  3. Average arterial line blood pressure

    Time frame: In implant procedure

    Evaluate average arterial line blood pressure during cardio-neural pacing, compared with that before the pacing.

  4. Fluoroscopic imaging

    Time frame: In implant procedure

    Collect fluoroscopic imaging to identify location and range of anatomical target area

Study contacts

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

Tsz Kin Mark 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
2026
Study completion
2027
First posted
Jun 5, 2025
Registry last updated
Jun 5, 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.