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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right Ventricular Outflow Tract (RVOT) Posterior Septum Pacing Group | Active Comparator |
| |
| Convention Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng Zheng, PhD | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
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| systemic mapping and ablation | Procedure | The TC or ST ablation catheter is delivered to ventricular outflow tract (VOT) to perform systemic mapping and ablation. |
|
| 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 |