Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Zero-fluoroscopy is the dream of all interventionists, and as low as reasonably achievable (ALARA) is the goal the investigators can manage at this moment. Trans-septal puncture (TSP) is the most pivotal step in the ablation procedure for left heart procedure, including atrial fibrillation ablation, and it is the only step that still needs fluoroscopy in the era of 3D electroanatomical map. With the incorporation of intracardiac echocardiography (ICE), the dream of zerofluoroscopy can be achieved.
Because the imaging offered by fluoroscopy or ICE is so different in terms of the advantages and shortages, the best TSP protocols might be different. Currently, in the literature, two techniques are commonly referred. However, no comparison has been made between these two techniques. Therefore, this study is to compare the safety and efficiency of these two techniques, also to observe the transition of a senior EP doctor who has been experienced in fluoroscopy-guided TSP, hoping to establish the learning curve for future reference of zerofluoroscopy promotion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echocardiography | Active Comparator | The movement of the puncture needle was monitored using intracardiac echocardiography rather than fluoroscopy. All other steps followed the conventional approach. |
|
| 3D mapping system | Experimental | Guided by the ablation catheter image on the 3D mapping system, the long sheath was advanced to the puncture site and then exchanged for a puncture needle. The entire procedure was monitored with intracardiac echocardiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| J Wire | Procedure | The movement of the puncture needle was monitored using intracardiac echocardiography rather than fluoroscopy. All other steps followed the conventional approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Total TSP time | Time duration from femoral venous access to the completion of both the first and second transseptal puncture (TSP). Unit of Measure: Minutes | Perioperative |
| Fluoroscopy usage and radiation dose | Whether fluoroscopy was used during the procedure and the corresponding radiation dose recorded if applicable. | during the procedure |
| Incidence of procedural complications | Occurrence of major complications during the procedure, including pericardial effusion, cardiac tamponade, stroke, or death. | up to 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospita | Taipei | 100 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3D mapping system | Procedure | Guided by the ablation catheter image on the 3D mapping system, the long sheath was advanced to the puncture site and then exchanged for a puncture needle. The entire procedure was monitored with intracardiac echocardiography. |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |