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

Not Applicable

Recruiting

• Conditions: Radio Frequency Catheter Ablation; Ventricular Outflow Tract Ventricular Arrhythmias
• Interventions: Procedure: systemic mapping and ablation; Procedure: Right Ventricular Outflow Tract Posterior Septum Pacing

• Registration Number: NCT06360003
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2024-03-28
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-07
• Last Update Submitted: 2024-04-07
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-04-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Convention Group	systemic mapping and ablation	-
Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group	Right Ventricular Outflow Tract Posterior Septum Pacing	-

Primary Outcome Measures

Name	Time	Method
Rate of Immediate Ablation Success	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.
Accuracy of RVOT posterior septal pacing protocol	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
Rate of Ablation Complication	At the end of the first procedure	Complications like cardiac tamponade, artery damage

Secondary Outcome Measures

Name	Time	Method
Incidence of Complication	3 months after first procedure	Complications like pericardial effusion, pseudo arterial aneurysm
Incidence of Complications Post-operative	period of post-operative to hospital discharge, within 7 days	Complications like cardiac tamponade, artery damage
Rate of Recurrence during Follow up	3 months after first procedure	Recurrence of the ventricular arrhythmia during the follow up period after catheter ablation procedure

Trial Locations

Locations (1)

Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China