Ventricular Outflow Tract Ventricular ArrhythmiasNCT06360003
"Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin
A study testing Right Ventricular Outflow Tract Posterior Septum Pacing and systemic mapping and ablation in people with Ventricular Outflow Tract Ventricular Arrhythmias and Radio Frequency Catheter Ablation, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ventricular Outflow Tract Ventricular Arrhythmias, Radio Frequency Catheter Ablation
- What is being tested?
- Right Ventricular Outflow Tract Posterior Septum Pacing and systemic mapping and ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 May 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent form
- Age more than 18 years old
- Able to understand the purpose of the experiment, voluntarily participate, willing to complete follow-up according to the requirement of the experimental protocol.
Who cannot join
- Severe cardiopulmonary, liver and kidney dysfunction, and inability to tolerate surgery due to coagulation dysfunction
- Viral myocarditis, myocardial infarction or stroke with a course of less than six months
- Simultaneously accompanied by malignant tumours, with an expected lifespan of less than or equal to 1 year
- Severe thoracic deformity
- Advanced age (more than 90 years old)
- Other situations that the researcher deems unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: "Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin: a Single-center, Prospective, Single Blind, Randomised Controlled Study
The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.
Researches will break the method of this investigation into two steps:
Read more
First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.
The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group.
- Being tested
- Right Ventricular Outflow Tract Posterior Septum Pacing, systemic mapping and ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Ventricular Outflow Tract Posterior Septum PacingProcedure or surgery
The Right Ventricular Outflow Tract (RVOT) posterior septum pacing is routinely performed to observe the QRS complex characteristics of the 12 lead ECG (with a focus on comparing their differences with the R-wave amplitude of spontaneous ventricular arrhythmias in the right chest (V1~V3) leads). When the pacing-induced R-wave amplitudes are all lower than spontaneous VAs in V1~V3, we predict the origin of Left Ventricular Outflow Tract (LVOT), mapping and ablation in LVOT; otherwise we predict the origin of RVOT, mapping and ablation in RVOT.If fails, go to the opposite site to do mapping and ablation. If still fails, go to distal great cardiac vein (DGCV) to do mapping and ablation.
systemic mapping and ablationProcedure or surgery
The TC or ST ablation catheter is delivered to ventricular outflow tract (VOT) to perform systemic mapping and ablation.
| Study group | Role | What they receive |
|---|---|---|
| Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group | Active comparator | Not described Receives: Procedure: Right Ventricular Outflow Tract Posterior Septum Pacing |
| Convention Group | Active comparator | Not described Receives: Procedure: systemic mapping and ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Immediate Ablation Success
Immediate Ablation Success is determined by the disappearance of ventricular arrhythmia after ablation, that cannot be induced by electrical stimulation and intravenous infusion of isoproterenol.
Measured: At the end of the first procedure
Rate of Ablation Complication
Complications like cardiac tamponade, artery damage
Measured: At the end of the first procedure
Accuracy of RVOT posterior septal pacing protocol
Target site predicted by RVOT posterior septal pacing protocol compared with actual target site and previous ecg criteria
Measured: At the end of the first procedure
Secondary outcomes (5)
Incidence of Complications Post-operative
Complications like cardiac tamponade, artery damage
Measured: period of post-operative to hospital discharge, within 7 days
Incidence of Complication
Complications like pericardial effusion, pseudo arterial aneurysm
Measured: 1 months after first procedure
Rate of Recurrence during Follow up
Recurrence of the ventricular arrhythmia during the follow up period after catheter ablation procedure
Measured: 1 months after first procedure
Incidence of Complication
Complications like pericardial effusion, pseudo arterial aneurysm
Measured: 3 months after first procedure
Rate of Recurrence during Follow up
Recurrence of the ventricular arrhythmia during the follow up period after catheter ablation procedure
Measured: 3 months after first procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2023
- Primary completion1 Feb 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Outflow Tract Ventricular ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng Zheng, PhD, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360003
- Sponsor's protocol ID
- SAHoWMU-CR2024-01-109
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin: a Single-center, Prospective, Single Blind, Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06360003
- Acronym / sponsor ID
- SAHoWMU-CR2024-01-109
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 11 Apr 2024 (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.
The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.
Researches will break the method of this investigation into two steps:
First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.
The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group | Active comparator | Procedure: Right Ventricular Outflow Tract Posterior Septum Pacing |
| Convention Group | Active comparator | Procedure: systemic mapping and ablation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sign informed consent form
- Age more than 18 years old
- Able to understand the purpose of the experiment, voluntarily participate, willing to complete follow-up according to the requirement of the experimental protocol.
Key exclusion criteria (6 listed)
- Severe cardiopulmonary, liver and kidney dysfunction, and inability to tolerate surgery due to coagulation dysfunction
- Viral myocarditis, myocardial infarction or stroke with a course of less than six months
- Simultaneously accompanied by malignant tumours, with an expected lifespan of less than or equal to 1 year
- Severe thoracic deformity
- Advanced age (more than 90 years old)
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 |
|---|---|---|
| Right Ventricular Outflow Tract Posterior Septum PacingThe Right Ventricular Outflow Tract (RVOT) posterior septum pacing is routinely performed to observe the QRS complex characteristics of the 12 lead ECG (with a focus on comparing their differences with the R-wave amplitude of spontaneous ventricular arrhythmias in the right chest (V1~V3) leads). When the pacing-induced R-wave amplitudes are all lower than spontaneous VAs in V1~V3, we predict the origin of Left Ventricular Outflow Tract (LVOT), mapping and ablation in LVOT; otherwise we predict the origin of RVOT, mapping and ablation in RVOT.If fails, go to the opposite site to do mapping and ablation. If still fails, go to distal great cardiac vein (DGCV) to do mapping and ablation. | Procedure or surgery | Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group |
| systemic mapping and ablationThe TC or ST ablation catheter is delivered to ventricular outflow tract (VOT) to perform systemic mapping and ablation. | Procedure or surgery | Convention Group |
Primary outcome
Rate of Immediate Ablation Success
Time frame: At the end of the first procedure
Immediate Ablation Success is determined by the disappearance of ventricular arrhythmia after ablation, that cannot be induced by electrical stimulation and intravenous infusion of isoproterenol.
Rate of Ablation Complication
Time frame: At the end of the first procedure
Complications like cardiac tamponade, artery damage
Accuracy of RVOT posterior septal pacing protocol
Time frame: At the end of the first procedure
Target site predicted by RVOT posterior septal pacing protocol compared with actual target site and previous ecg criteria
5 secondary outcomes
Incidence of Complications Post-operative
Time frame: period of post-operative to hospital discharge, within 7 days
Incidence of Complication
Time frame: 1 months after first procedure
Rate of Recurrence during Follow up
Time frame: 1 months after first procedure
Incidence of Complication
Time frame: 3 months after first procedure
Rate of Recurrence during Follow up
Time frame: 3 months after first 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 28 Apr 2026.
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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.
Cheng Zheng, PhD principal investigator
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Ventricular Outflow Tract Posterior Septum Pacing and systemic mapping and ablation in people with Ventricular Outflow Tract Ventricular Arrhythmias and Radio Frequency Catheter Ablation, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site 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 3 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 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rate of Immediate Ablation Success (time frame: At the end of the first procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2026.