- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05573178
Different Catheter Ablation Strategy in Vasovagal Syncope
Different Catheter Ablation Strategy in Vasovagal Syncope: A Single Center, Prospective, Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yao yan, PhD
- Phone Number: 13901121319
- Email: ianyao@263.net.cn
Study Contact Backup
- Name: zheng lihui, PhD
- Phone Number: 13910617612
- Email: zhenglihui@263.net
Study Locations
-
-
-
Beijing, China
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
-
-
Beijing
-
Beijing, Beijing, China, 100037
- China National Center for Cardiovascular Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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, 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ablation of left atrial ganglion plexus
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).
|
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.
|
Experimental: combined ablation of left and right atrial ganglion plexus
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with syncope during follow up
Time Frame: 12 month after ablation procedure
|
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
Time Frame: 12 month after ablation procedure
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with positive results of head-upright tilt test
Time Frame: 6 month after ablation procedure
|
the positive results of head-upright tilt test were defined by VASIS standard
|
6 month after ablation procedure
|
Number of Participants with positive results of head-upright tilt test
Time Frame: 12 month after ablation procedure
|
the positive results of head-upright tilt test were defined by VASIS standard
|
12 month after ablation procedure
|
changes of deceleration capacity compare to baseline
Time Frame: 3 days after ablation procedure
|
The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.
|
3 days after ablation procedure
|
changes of deceleration capacity compare to baseline
Time Frame: 3 month after ablation procedure
|
The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.
|
3 month after ablation procedure
|
changes of deceleration capacity compare to baseline
Time Frame: 6 month after ablation procedure
|
The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.
|
6 month after ablation procedure
|
changes of deceleration capacity compare to baseline
Time Frame: 9 month after ablation procedure
|
The deceleration capacity was calculated with the 24-hour ambulatory electrocardiogram through the phase-rectified signal averaging technique.
|
9 month after ablation procedure
|
Collaborators and Investigators
Investigators
- Study Chair: Yao yan, PhD, Fuwai Hospital, National Center for Cardiovascular Diseases
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019XK320059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Syncope, Vasovagal
-
University of CalgaryNot yet recruitingSyncope | Vasovagal Syncope (VVS)Canada
-
David B. De LurgioBiosense Webster, Inc.CompletedNeurocardiogenic Syncope | Vasovagal SyncopeUnited States
-
Hospices Civils de LyonNot yet recruiting
-
University of CalgaryRecruiting
-
Dr. Bob SheldonVanderbilt UniversityActive, not recruitingVasovagal SyncopeUnited States, Canada, Poland
-
University of CalgaryCardiac Arrhythmia Network of CanadaCompleted
-
University of CalgaryVanderbilt UniversityActive, not recruitingVasovagal SyncopeCanada
-
Aarhus University Hospital SkejbyAarhus University Hospital; Biotronik SE & Co. KGCompleted
-
University of CalgaryCanadian Institutes of Health Research (CIHR)CompletedSyncope, Vasovagal, Neurally-MediatedUnited States, Canada
Clinical Trials on cardiac ganglion plexus ablation(cardioneuroablation)
-
China National Center for Cardiovascular DiseasesChinese Academy of Medical Sciences, Fuwai Hospital; Shanghai Jiaotong University... and other collaboratorsUnknownSick Sinus Syndrome | Permanent Pacemaker Implantation | Cardioneuroablation | Ganglionated PlexusChina
-
Hospital Clinico Universitario de SantiagoSpanish Society of Cardiology; Hospital Universitario Lucus AugustiRecruitingSick Sinus Syndrome | Sinus Node DysfunctionSpain
-
St. Joseph's Centre, PolandCompletedAtrial Fibrillation ParoxysmalPoland
-
Meshalkin Research Institute of Pathology of CirculationUnknownPulmonary HypertensionRussian Federation
-
St. Joseph's Centre, PolandNot yet recruitingAtrial Fibrillation Paroxysmal
-
China National Center for Cardiovascular DiseasesFirst Affiliated Hospital, Sun Yat-Sen University; RenJi Hospital; First Affiliated... and other collaboratorsRecruiting
-
David B. De LurgioBiosense Webster, Inc.CompletedNeurocardiogenic Syncope | Vasovagal SyncopeUnited States
-
West Virginia UniversityRecruiting
-
Ning ZhouNot yet recruitingAtrial Fibrillation, Persistent | Catheter Ablation | Ganglionated Plexi
-
Medtronic Cardiac Rhythm and Heart FailureCompleted