Completed

NCT Number: NCT06360003

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

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.

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Key information

Conditions

Ventricular Outflow Tract Ventricular Arrhythmias Radio Frequency Catheter Ablation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Right Ventricular Outflow Tract Posterior Septum Pacing

Procedure

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 ablation

Procedure

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

Primary outcomes

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

Secondary outcomes

Incidence of Complications Post-operative

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

Complications like cardiac tamponade, artery damage
Incidence of Complication

Time frame: 1 months after first procedure

Complications like pericardial effusion, pseudo arterial aneurysm
Rate of Recurrence during Follow up

Time frame: 1 months after first procedure

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

Time frame: 3 months after first procedure

Complications like pericardial effusion, pseudo arterial aneurysm
Rate of Recurrence during Follow up

Time frame: 3 months after first procedure

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Apr 11, 2024
Registry last updated: Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.