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.
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
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.
- Conditions
- Syncope, Vasovagal
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Procedure: cardiac ganglion plexus ablation(cardioneuroablation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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.
- First posted10 Oct 2022
- Study start26 Dec 2020
- Primary completion20 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yan Yao, MD,PhD, China National Center for Cardiovascular Diseases
- Investigators
- Yao yan, PhD, Study chair, Fuwai Hospital, National Center for Cardiovascular Diseases
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 31760820Zhu 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 31439288Tu 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Catheter Ablation Strategy in Vasovagal Syncope: A Single Center, Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT05573178
- Acronym / sponsor ID
- 2019XK320059
- Conditions
- Syncope, Vasovagal
- Keywords
- Vasovagal syncope, cardioneuroablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 26 Dec 2020 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 10 Oct 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation of left atrial ganglion plexus | Experimental | Procedure: cardiac ganglion plexus ablation(cardioneuroablation)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). |
| combined ablation of left and right atrial ganglion plexus | Experimental | Procedure: cardiac ganglion plexus ablation(cardioneuroablation)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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| cardiac ganglion plexus ablation(cardioneuroablation)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. | Procedure or surgery | Ablation of left atrial ganglion plexus, combined ablation of left and right atrial ganglion plexus |
Primary outcome
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.
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.
6 secondary outcomes
Number of Participants with positive results of head-upright tilt test
Time frame: 6 month after ablation procedure
Number of Participants with positive results of head-upright tilt test
Time frame: 12 month after ablation procedure
changes of deceleration capacity compare to baseline
Time frame: 3 days after ablation procedure
changes of deceleration capacity compare to baseline
Time frame: 3 month after ablation procedure
changes of deceleration capacity compare to baseline
Time frame: 6 month after ablation procedure
changes of deceleration capacity compare to baseline
Time frame: 9 month after ablation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Results publication: PubMed 31760820Hu 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 publication: PubMed 31439288Zhu 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.
- Derived from this study: PubMed 40117421Tu 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.
- article on pubmedLink provided by the sponsor.
- article on pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yao yan, PhD study chair
Fuwai Hospital, National Center for Cardiovascular Diseases
2 sites in 1 country: see every site and its status.
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.