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

NCT07007000 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-05

No results posted yet for this study

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

Interventions

DEVICE

Temporary cardio-neural pacing

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-09-30
Completion
2027-03-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07007000 on ClinicalTrials.gov