Temporary Cardio-neural PacingNCT07247422
Cardioneural Temporary Pacing to Achieve Autonomic Modulation
A study testing Temporary cardio-neural pacing in people with Temporary Cardio-neural Pacing and Pacemaker Implantation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Temporary Cardio-neural Pacing, Pacemaker Implantation
- What is being tested?
- Temporary cardio-neural pacing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteHong Kong
- Study dates
- Dec 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who cannot provide informed consent
- Patients < 18 years old
- Pregnant patients
- Illiterate patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Prince of Wales Hospital
Hong Kong, Sha Tin
Tammy Yeung, 852 35051750, tammyooyeung@cuhk.edu.hk
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Temporary cardio-neural pacing
- Keywords
- cardio-neural pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary cardio-neural pacingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| temporary cardio-neural pacing | Experimental | Patient will undergo temporary cardio-neural pacing in study procedure Receives: Procedure: Temporary cardio-neural pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate equal or lower than 80bpm
Number of patients achieving <=80bpm heart rate with cardio-neural pacing
Measured: In implant procedure
Secondary outcomes (5)
Threshold
Pacing threshold to achieve HR<=80 with CNP.
Measured: In implant procedure
Patient discomfort
Number of patients with discomfort from patient during CNP
Measured: In implant procedure
Mean blood pressure
Mean blood pressure during CNP, compared with that before pacing.
Measured: In implant procedure
Blood Biochemistry
Change of blood biochemistry including lactate level and pH in blood gas.
Measured: In implant procedure
Inotrope dosage
Determine Inotrope dosage
Measured: In implant procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporary Cardio-neural PacingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tam Tsz Kin, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247422
- Sponsor's protocol ID
- Temp CNP Study
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioneural Temporary Pacing to Achieve Autonomic Modulation
- ClinicalTrials.gov ID
- NCT07247422
- Acronym / sponsor ID
- Temp CNP Study
- Keywords
- cardio-neural pacing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| temporary cardio-neural pacing | Experimental | Procedure: Temporary cardio-neural pacingPatient will undergo temporary cardio-neural pacing in study procedure |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Patients who cannot provide informed consent
- Patients < 18 years old
- Pregnant patients
- Illiterate patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary cardio-neural pacingArterial 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. | Procedure or surgery | temporary cardio-neural pacing |
Primary outcome
Heart Rate equal or lower than 80bpm
Time frame: In implant procedure
Number of patients achieving <=80bpm heart rate with cardio-neural pacing
5 secondary outcomes
Threshold
Time frame: In implant procedure
Patient discomfort
Time frame: In implant procedure
Mean blood pressure
Time frame: In implant procedure
Blood Biochemistry
Time frame: In implant procedure
Inotrope dosage
Time frame: In implant procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary cardio-neural pacing in people with Temporary Cardio-neural Pacing and Pacemaker Implantation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tsz Kin Tam (852 35051750, marktam@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate equal or lower than 80bpm (time frame: In implant procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.