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

NCT06360003 | Completed

• 1 other identifier: SAHoWMU-CR2024-01-109
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Outflow Tract Ventricular Arrhythmias; Radio Frequency Catheter Ablation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Incidence of Complications Post-operative

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

• Incidence of Complication

  1 months after first procedure

• Rate of Recurrence during Follow up

  1 months after first procedure

• Incidence of Complication

  3 months after first procedure

• Rate of Recurrence during Follow up

  3 months after first procedure

Study Arms (2)

Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group

ACTIVE COMPARATOR

Procedure: Right Ventricular Outflow Tract Posterior Septum Pacing

Convention Group

ACTIVE COMPARATOR

Procedure: systemic mapping and ablation

Interventions

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.

Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group

systemic mapping and ablation PROCEDURE

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

Convention Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Wenzhou, Zhejiang, 325000, China

Location

Study Officials

• Cheng Zheng, PhD

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)