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

NCT07007000 | Not Yet Recruiting

• 1 other identifier: CNP study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardio-neural Pacing

Outcome Measures

Primary Outcomes (1)

• Percentage prolongation of CL

  Measure percentage prolongation of CL with lead fixation

  In implant procedure

Secondary Outcomes (4)

• Threshold

  In implant procedure

• Discomfort

  In implant procedure

• Average arterial line blood pressure

  In implant procedure

• Fluoroscopic imaging

  In implant procedure

Study Arms (1)

Cardio-neural pacing

OTHER

Patient will undergo temporary cardio-neural pacing during implantation of pacemaker

Device: Temporary cardio-neural pacing

Interventions

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 3V@0.4ms. 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.

Cardio-neural pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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, Hong Kong

Location

Central Study Contacts

Tsz Kin Mark 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: May 28, 2025
• First Posted: June 5, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

HK (1)