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

NCT ID: NCT06360003

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-08-01

Brief Summary

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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

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Conditions

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Ventricular Outflow Tract Ventricular Arrhythmias Radio Frequency Catheter Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group

Group Type ACTIVE_COMPARATOR

Right Ventricular Outflow Tract Posterior Septum Pacing

Intervention Type 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.

Convention Group

Group Type ACTIVE_COMPARATOR

systemic mapping and ablation

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

systemic mapping and ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cheng Zheng, PhD

Role: CONTACT

86-0577-85676609

Facility Contacts

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Cheng Zheng, PhD

Role: primary

86-0577-85676609

Other Identifiers

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SAHoWMU-CR2024-01-109

Identifier Type: -

Identifier Source: org_study_id

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