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Syncope, VasovagalNCT05573178

Different Catheter Ablation Strategy in Vasovagal Syncope

A study testing cardiac ganglion plexus ablation(cardioneuroablation) in people with Syncope, Vasovagal, run by China National Center for Cardiovascular Diseases at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a prospective, single-center randomized controlled clinical trial. patients with refractory vasovagal syncope were randomly divided into two groups according to the proportion of 1:1. Read more about this study

Who is it for?
Any age
Conditions the study is for
Syncope, Vasovagal
What is being tested?
cardiac ganglion plexus ablation(cardioneuroablation)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesChina
Study dates
26 Dec 2020to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Sign the informed consent form.
  • Definitely diagnosed as vasovagal syncope (according to the 2018 ESC syncope diagnosis and management guidelines).
  • Positive head-up tilt test (cardiac inhibition type, mixed type).
  • Syncope attacks ≥ 3 times in 1 year before operation and/or recurrence of syncope in the last 6 months.
  • More than 2 kinds of routine treatment were ineffective or could not tolerate their side effects.

Who cannot join

  • Syncope caused by other causes.
  • Heart failure (NYHA grade Ⅲ or IV), congenital heart disease, valvular heart disease, deficiency. Bloody heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic cardiomyopathy and myocarditis, chronic. Hepatic and renal insufficiency, diabetes, nervous system diseases, etc.
  • Acute coronary syndrome or myocardial infarction occurred in recent 6 months; cerebrovascular events occurred in recent 3 months (such as short. Transient ischemic attack, stroke) or other disturbance of cerebral blood supply.
  • Previously undergone cardiac catheter ablation, cardiac surgery and / or permanent cardiac pacemaker implantation.
  • Left atrial thrombus and / or left atrial diameter > 55mm or EF < 35% were found by echocardiography or CT.
  • Pregnancy and lactation.

Trial locations and contacts

2 sites in 1 country.

China2 sites
  • China National Center for Cardiovascular Diseases

    Beijing, Beijing Municipality, 100037

  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing

Other trials in China

About this study

Official title: Different Catheter Ablation Strategy in Vasovagal Syncope: A Single Center, Prospective, Randomized Study

This study is a prospective, single-center randomized controlled clinical trial. patients with refractory vasovagal syncope were randomly divided into two groups according to the proportion of 1:1. Group A: simple left atrial ganglion plexus ablation (RAGP + LSGP + LLGP + LIGP + RIGP ablation); B group: left atrial ganglion plexus combined with right atrial ganglion plexus ablation (group A + consolidation ablation of RAGP at the junction of right atrial septum and superior vena cava). To clarify the role of RAGP in cardiac autonomic nervous system and the effect of ablation, to establish the standard stragtegy of cardiac nerve ablation.

Read the detailed description

Vasovagal syncope (VVS) is the most common syncope type in clinic, but routine therapy shows no benefits. Cardiac nerve ablation affects the function of cardiovascular system by accurately mapping and ablation of cardiac autonomic ganglion plexus and adjusting cardiac sympathetic-vagal balance. The existing clinical evidence is mostly exploratory or registered clinical studies, and the sample size is small. This study intends to adopt a prospective, randomized controlled study to compare the efficacy of simple left atrial ganglion plexus ablation and left atrial ganglion plexus ablation combined with right atrial ganglion plexus ablation in the treatment of VVS, and to establish the relevant cardiac nerve ablation standards.

This study is a prospective, single-center randomized controlled clinical trial. patients with refractory vasovagal syncope were randomly divided into two groups according to the proportion of 1:1. Group A: simple left atrial ganglion plexus ablation (RAGP + LSGP + LLGP + LIGP + RIGP ablation); B group: left atrial ganglion plexus combined with right atrial ganglion plexus ablation (group A + consolidation ablation of RAGP at the junction of right atrial septum and superior vena cava).

Atrial modeling was established under the guidance of Ensite three-dimensional mapping system, and then MicroPace EPS 320 was used to stimulate and induce the main distribution areas of autonomic ganglia. The high frequency stimulation mode is set as follows: the stimulation frequency is 20 Hz, the voltage is 10 to 20 volts, and the pulse width is 5 milliseconds. The main sites of high frequency stimulation include: the left superior pulmonary vein and the left atrial posterior wall of LSGP, the left inferior pulmonary vein orifice of LIGP, the LLGP, around the right inferior pulmonary vein orifice, the RIGP, around the right superior pulmonary vein and the left atrial junction of the right superior pulmonary vein, the right atrial septum of RAGP, and the superior vena cava junction to stimulate RAGP. Ganglion localization standard: locate the site of vagal response (ventricular arrest, atrioventricular block, RR interval prolongation at least 50%) after high frequency stimulation, and mark it in the three-dimensional model.

Under the guidance of three-dimensional system, the located ganglion plexus was ablated with saline irrigating electrode. The upper limit of power was 40W, the upper limit of temperature was 43 ℃, and the washing rate of saline was 17ml/min. The site of vagal reaction during ablation was defined as the effective ablation site . Denervated interventional therapy. The surgical end point of the treatment was defined as the disappearance of vagal response at the effective ablation site or the ablation of each effective point discharge for at least 30 seconds. Cardiac electrophysiological parameters such as heart rate, AH interval, HV interval, recovery time of sinoatrial node, Wenckebach point of atrioventricular conduction and atrioventricular conduction refractory period were measured before and after ablation.

The patients were followed up at 3 months, 6 months, 12 months and 24 months respectively after ablation procedure, to observe whether there were recurrent syncope and /or pre-syncope (including the time and frequency of recurrent syncope, inducing factors, and whether complicated with fall injury, etc.), and to reassessed tilt test, 24-hour ambulatory electrocardiogram and fill in Short Form-36 (SF-36) and Euroqol (EQ-5D) quality of life score form. To evaluate the safety and efficacy of cardiac nerve ablation in the prevention of refractory vasovagal syncope. The tilt test, the changes of vagus nerve function and the improvement of quality of life before and after were analyzed and compared. To evaluate the efficacy and safety of cardiac nerve ablation strategies, and to explore the role and optimization of RAGP in cardiac nerve ablation.

Being tested
cardiac ganglion plexus ablation(cardioneuroablation)
Keywords
Vasovagal syncope, cardioneuroablation
Medical subject headings
Syncope, Vasovagal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiac ganglion plexus ablation(cardioneuroablation)Procedure or surgery

    Under the guidance of three-dimensional system, the located ganglion plexus was ablated with saline irrigating electrode. The upper limit of power was 40W, the upper limit of temperature was 43 ℃, and the washing rate of saline was 17ml/min. The site of vagal reaction during ablation was defined as the effective ablation site. The surgical end point of denervated interventional therapy is defined as the disappearance of vagal response at the effective ablation site or the ablation of each effective point discharge for at least 30 seconds.

Study groups in NCT05573178
Study groupRoleWhat they receive
Ablation of left atrial ganglion plexusExperimentalIn this arm, ablation of GPs will only performed in the left atrium, including ablation of right anterior ganglion plexus (RAGP),left superior ganglion plexus (LSGP),left ganglion plexus (LLGP), left interior ganglion plexus (LIGP) and right interior ganglion plexus(RIGP).
Receives: Procedure: cardiac ganglion plexus ablation(cardioneuroablation)
combined ablation of left and right atrial ganglion plexusExperimentalIn the arm the, ablation of GPs will perform in both atrium, including ablation of right anterior ganglion plexus (RAGP),left superior ganglion plexus (LSGP),left ganglion plexus (LLGP), left interior ganglion plexus (LIGP), right interior ganglion plexus (RIGP), and superior vena cava ganglion plexus (SVCGP). SVCGP were ablated in the right atrium,the left GPs were ablated through the left atrium
Receives: Procedure: cardiac ganglion plexus ablation(cardioneuroablation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with syncope during follow up

    Syncope was defined as a transient loss of consciousness and complete recovery in a very short time. We documented each time that syncope occurred.

    Measured: 12 month after ablation procedure

  2. Number of Participants with pre-syncope during follow up

    Pre-syncope was defined as the prodrome before syncope, such as dizziness, sweating, dyspnea, and paleness, and patients did not actually fall down. We documented each time that syncope occurred.

    Measured: 12 month after ablation procedure

Secondary outcomes (6)
  1. Number of Participants with positive results of head-upright tilt test

    the positive results of head-upright tilt test were defined by VASIS standard

    Measured: 6 month after ablation procedure

  2. Number of Participants with positive results of head-upright tilt test

    the positive results of head-upright tilt test were defined by VASIS standard

    Measured: 12 month after ablation procedure

  3. changes of deceleration capacity compare to baseline

    The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.

    Measured: 3 days after ablation procedure

  4. changes of deceleration capacity compare to baseline

    The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.

    Measured: 3 month after ablation procedure

  5. changes of deceleration capacity compare to baseline

    The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.

    Measured: 6 month after ablation procedure

  6. changes of deceleration capacity compare to baseline

    The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.

    Measured: 9 month after ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start26 Dec 2020
  3. Primary completion20 Nov 2023
  4. Study completion30 Nov 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05573178
Sponsor's protocol ID
2019XK320059
Status last verified
Nov 2023
First submitted
27 Jan 2021
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hu F, Zheng L, Liu S, Shen L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Avoidance of Vagal Response During Circumferential Pulmonary Vein Isolation: Effect of Initiating Isolation From Right Anterior Ganglionated Plexi. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007811. doi: 10.1161/CIRCEP.119.007811. Epub 2019 Nov 25.

    PubMed 31760820
  • Zhu C, Hanna P, Rajendran PS, Shivkumar K. Neuromodulation for Ventricular Tachycardia and Atrial Fibrillation: A Clinical Scenario-Based Review. JACC Clin Electrophysiol. 2019 Aug;5(8):881-896. doi: 10.1016/j.jacep.2019.06.009. Epub 2019 Aug 19.

    PubMed 31439288
  • Tu B, Chen A, Cai S, Zhang Z, Zhou L, Lai Z, Maimaitijiang P, Hu Z, Wu L, Ding L, Zheng L, Yao Y. The Efficacy of Left Atrial vs Biatrial Cardioneuroablation in Patients With Vasovagal Syncope: A Randomized Clinical Trial. JACC Clin Electrophysiol. 2025 Jun;11(6):1265-1276. doi: 10.1016/j.jacep.2025.01.019. Epub 2025 Mar 19.

    PubMed 40117421

Questions about this trial

What is this clinical trial studying?

A study testing cardiac ganglion plexus ablation(cardioneuroablation) in people with Syncope, Vasovagal, run by China National Center for Cardiovascular Diseases at 2 sites in China.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with syncope during follow up (time frame: 12 month after ablation procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05573178, which also lists 3 linked publications.

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 1 Dec 2023.

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