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CompletedNCT06360003Updated Apr 28, 2026

"Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin

An interventional study of Right Ventricular Outflow Tract Posterior Septum Pacing and systemic mapping and ablation in Ventricular Outflow Tract Ventricular Arrhythmias and Radio Frequency Catheter Ablation, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
109
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ventricular Outflow Tract Ventricular Arrhythmias
  • Radio Frequency Catheter Ablation
03

In context

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
109 participants (actual)

Study arms

  • Active comparator
    Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group

    Procedure: Right Ventricular Outflow Tract Posterior Septum Pacing

  • Active comparator
    Convention Group

    Procedure: systemic mapping and ablation

Interventions

  • ProcedureRight Ventricular Outflow Tract Posterior Septum Pacing

    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.

  • Proceduresystemic mapping and ablation

    The TC or ST ablation catheter is delivered to ventricular outflow tract (VOT) to perform systemic mapping and ablation.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the end of the first procedure

  2. Rate of Ablation Complication

    Complications like cardiac tamponade, artery damage

    Time frame: At the end of the first procedure

  3. 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

    Time frame: At the end of the first procedure

Secondary outcomes

  1. Incidence of Complications Post-operative

    Complications like cardiac tamponade, artery damage

    Time frame: period of post-operative to hospital discharge, within 7 days

  2. Incidence of Complication

    Complications like pericardial effusion, pseudo arterial aneurysm

    Time frame: 1 months after first procedure

  3. Rate of Recurrence during Follow up

    Recurrence of the ventricular arrhythmia during the follow up period after catheter ablation procedure

    Time frame: 1 months after first procedure

  4. Incidence of Complication

    Complications like pericardial effusion, pseudo arterial aneurysm

    Time frame: 3 months after first procedure

  5. Rate of Recurrence during Follow up

    Recurrence of the ventricular arrhythmia during the follow up period after catheter ablation procedure

    Time frame: 3 months after first procedure

07

Study locations

1 site
  • Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06360003
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Apr 11, 2024
Start date
Apr 1, 2023
Primary completion
Feb 1, 2025
Completion
May 1, 2025
Last update
Apr 28, 2026

Study contacts

Cheng Zheng, PhD
principal investigator · Second Affiliated Hospital of Wenzhou Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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