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Different Catheter Ablation Strategy in Vasovagal Syncope

Primary Purpose

Syncope, Vasovagal

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cardiac ganglion plexus ablation(cardioneuroablation)
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Syncope, Vasovagal focused on measuring Vasovagal syncope, cardioneuroablation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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, vascular 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.

Exclusion Criteria:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ablation of left atrial ganglion plexus

combined ablation of left and right atrial ganglion plexus

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Number of Participants with positive results of head-upright tilt test
the positive results of head-upright tilt test were defined by VASIS standard
Number of Participants with positive results of head-upright tilt test
the positive results of head-upright tilt test were defined by VASIS standard
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.
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.
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.
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.

Full Information

First Posted
January 27, 2021
Last Updated
October 7, 2022
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05573178
Brief Title
Different Catheter Ablation Strategy in Vasovagal Syncope
Official Title
Different Catheter Ablation Strategy in Vasovagal Syncope: A Single Center, Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal
Keywords
Vasovagal syncope, cardioneuroablation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ablation of left atrial ganglion plexus
Arm Type
Experimental
Arm Description
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).
Arm Title
combined ablation of left and right atrial ganglion plexus
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
cardiac ganglion plexus ablation(cardioneuroablation)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with syncope during follow up
Description
Syncope was defined as a transient loss of consciousness and complete recovery in a very short time. We documented each time that syncope occurred.
Time Frame
12 month after ablation procedure
Title
Number of Participants with pre-syncope during follow up
Description
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.
Time Frame
12 month after ablation procedure
Secondary Outcome Measure Information:
Title
Number of Participants with positive results of head-upright tilt test
Description
the positive results of head-upright tilt test were defined by VASIS standard
Time Frame
6 month after ablation procedure
Title
Number of Participants with positive results of head-upright tilt test
Description
the positive results of head-upright tilt test were defined by VASIS standard
Time Frame
12 month after ablation procedure
Title
changes of deceleration capacity compare to baseline
Description
The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.
Time Frame
3 days after ablation procedure
Title
changes of deceleration capacity compare to baseline
Description
The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.
Time Frame
3 month after ablation procedure
Title
changes of deceleration capacity compare to baseline
Description
The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.
Time Frame
6 month after ablation procedure
Title
changes of deceleration capacity compare to baseline
Description
The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.
Time Frame
9 month after ablation procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, vascular 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao yan, PhD
Phone
13901121319
Email
ianyao@263.net.cn
First Name & Middle Initial & Last Name or Official Title & Degree
zheng lihui, PhD
Phone
13910617612
Email
zhenglihui@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yao yan, PhD
Organizational Affiliation
Fuwai Hospital, National Center for Cardiovascular Diseases
Official's Role
Study Chair
Facility Information:
Facility Name
China National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan YAO, MD, PhD
Phone
+86-13901121319
Email
ianyao@263.net.cn
First Name & Middle Initial & Last Name & Degree
Shangyu LIU, MD
Phone
+86-18800161355
Email
liushangyu_fw@163.com
Facility Name
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Yan, MD PhD
Phone
+86-1390-1121-319
Email
ianyao@263.net.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31760820
Citation
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.
Results Reference
result
PubMed Identifier
31439288
Citation
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.
Results Reference
result
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/31760820/
Description
article on pubmed
URL
http://pubmed.ncbi.nlm.nih.gov/31439288/
Description
article on pubmed

Learn more about this trial

Different Catheter Ablation Strategy in Vasovagal Syncope

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