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

"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:

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 Overview

• Status: Completed
• Conditions: Ventricular Outflow Tract Ventricular Arrhythmias; Radio Frequency Catheter Ablation
• Intervention / Treatment: Procedure: Right Ventricular Outflow Tract Posterior Septum Pacing; Procedure: systemic mapping and ablation

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group	Procedure: Right 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.
Active Comparator: Convention Group	Procedure: systemic mapping and ablation; The TC or ST ablation catheter is delivered to ventricular outflow tract (VOT) to perform systemic mapping and ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the end of the first procedure
Rate of Ablation Complication	Complications like cardiac tamponade, artery damage	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	At the end of the first procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Complications Post-operative	Complications like cardiac tamponade, artery damage	period of post-operative to hospital discharge, within 7 days
Incidence of Complication	Complications like pericardial effusion, pseudo arterial aneurysm	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	1 months after first procedure
Incidence of Complication	Complications like pericardial effusion, pseudo arterial aneurysm	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	3 months after first procedure

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Cheng Zheng, PhD, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: SAHoWMU-CR2024-01-109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No