Different Catheter Ablation Strategy in Vasovagal Syncope

NCT05573178 | Completed DMC

• 1 other identifier: 2019XK320059
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Syncope, Vasovagal

Keywords

Vasovagal syncope; cardioneuroablation

Outcome Measures

Primary Outcomes (2)

• 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.

  12 month after ablation procedure

• 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.

  12 month after ablation procedure

Secondary Outcomes (6)

• Number of Participants with positive results of head-upright tilt test

  6 month after ablation procedure

• Number of Participants with positive results of head-upright tilt test

  12 month after ablation procedure

• changes of deceleration capacity compare to baseline

  3 days after ablation procedure

• changes of deceleration capacity compare to baseline

  3 month after ablation procedure

• changes of deceleration capacity compare to baseline

  6 month after ablation procedure

Study Arms (2)

Ablation of left atrial ganglion plexus

EXPERIMENTAL

In 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).

Procedure: cardiac ganglion plexus ablation(cardioneuroablation)

combined ablation of left and right atrial ganglion plexus

EXPERIMENTAL

In 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

Procedure: cardiac ganglion plexus ablation(cardioneuroablation)

Interventions

cardiac ganglion plexus ablation(cardioneuroablation) PROCEDURE

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.

Ablation of left atrial ganglion plexus; combined ablation of left and right atrial ganglion plexus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (2)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

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

Beijing, China

Location

Related Publications (3)

• 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.

  PMID: 31760820 RESULT

• 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.

  PMID: 31439288 RESULT

• 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.

  PMID: 40117421 DERIVED

Related Links

• article on pubmed
• article on pubmed

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yao yan, PhD

  Fuwai Hospital, National Center for Cardiovascular Diseases

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of First Department of Arrythmia Center

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: October 10, 2022
• Study Start: December 26, 2020
• Primary Completion: November 20, 2023
• Study Completion: November 30, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)