Clinical trial NCT06360003: "Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Outflow Tract Ventricular Arrhythmias
Radio Frequency Catheter Ablation
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Immediate Ablation Success
timeFrame: At the end of the first procedure
measure: Rate of Ablation Complication
timeFrame: At the end of the first procedure
measure: Accuracy of RVOT posterior septal pacing protocol
timeFrame: At the end of the first procedure
Secondary outcomes:
measure: Incidence of Complications Post-operative
timeFrame: period of post-operative to hospital discharge, within 7 days
measure: Incidence of Complication
timeFrame: 1 months after first procedure
measure: Rate of Recurrence during Follow up
timeFrame: 1 months after first procedure
measure: Incidence of Complication
timeFrame: 3 months after first procedure
measure: Rate of Recurrence during Follow up
timeFrame: 3 months after first procedure
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
name: Cheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: