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| Name | Class |
|---|---|
| Fu Wai Hospital, Beijing, China | OTHER |
| Xinyang Central Hospital | OTHER |
| Ningbo No. 1 Hospital | OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine |
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This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
Catheter ablation is a well-established treatment to treat patients with a wide range of heart rhythm disturbances. Fluoroscopy is a imaging modality routinely used for the ablation of arrhythmias.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs; three-dimensional mapping systems, including CARTO and Ensite NavX, have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers. Ensite NavX system can be used for zero-fluoroscopy approach for catheter ablation of arrhythmias. This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopy approach using Ensite NavX as the only imaging modality with conventional fluoroscopic approach for the catheter ablation of idiopathic ventricular arrhythmias; conventional fluoroscopic approach use fluoroscopy plus Ensite NavX or plus Carto as the imaging modality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero-fluoroscopy ablation | Experimental | Zero-fluoroscopy ablation will be performed under the guidance of Ensite NavX for mapping and ablation and fluoroscopy will not be used during the procedure. |
|
| Conventional fluoroscopy ablation | Active Comparator | Conventional fluoroscopy ablation will be performed under fluoroscopic guidance plus Ensite NavX for mapping and ablation during the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zero-fluoroscopy ablation | Procedure | Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rates | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total procedure time | during procedure | |
| Fluoroscopy time | during procedure | |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Wang, PhD | Contact | 86-27-83663280 | newswangyan@tjh.tjmu.edu.cn | |
| Guangzhi Chen, PhD | Contact | 86-27-83662842 | chengz2003@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Wang, PhD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25432138 | Background | Andrade JG, Rivard L, Macle L. The past, the present, and the future of cardiac arrhythmia ablation. Can J Cardiol. 2014 Dec;30(12 Suppl):S431-41. doi: 10.1016/j.cjca.2014.07.731. Epub 2014 Jul 24. | |
| 22526222 | Background | Anselmino M, Sillano D, Casolati D, Ferraris F, Scaglione M, Gaita F. A new electrophysiology era: zero fluoroscopy. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):221-7. doi: 10.2459/JCM.0b013e3283536555. |
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| OTHER |
| Guangxi Medical University | OTHER |
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| Conventional fluoroscopy ablation | Procedure | Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX. |
|
| 1 year |
| Immediate success rate | 10~30minutes |
| 24273563 | Background | Kozluk E, Gawrysiak M, Piatkowska A, Lodzinski P, Kiliszek M, Malkowska S, Zaczek R, Piatkowski R, Opolski G, Kozlowski D. Radiofrequency ablation without the use of fluoroscopy - in what kind of patients is it feasible? Arch Med Sci. 2013 Oct 31;9(5):821-5. doi: 10.5114/aoms.2013.38676. Epub 2013 Nov 5. |
| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
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