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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Xiangyang Central Hospital | OTHER |
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This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. Recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero-fluoroscopic ablation | Experimental | Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy. |
|
| Conventional fluoroscopic ablation | Active Comparator | Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zero-fluoroscopic ablation | Device | Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rate | Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Complications were defined as pseudoaneurysm, arterialvenous fistula, pneumothorax, second- or third-degree atrioventricular block, cardiac tamponade, or other serious complications requiring intervention. | one year |
| Immediate success rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Wang, PhD | Tongji Hospital Wuhan, Hubei China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 26034742 | Background | Mobinizadeh M, Arabloo J, Hamouzadeh P, Akbari Sari A. A systematic review of the effectiveness of catheter ablation NavX mapping system for treatment of the cardiac arrhythmia. Med J Islam Repub Iran. 2015 Mar 10;29:189. eCollection 2015. |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| First Affiliated Hospital of Guangxi Medical University |
| OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Morristown Memorial Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Ningbo No. 1 Hospital | OTHER |
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| Conventional fluoroscopic ablation | Device | Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy. |
|
Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine. |
| one day |
| Recurrence Rate | 2. An ECG and electrophysiology study would be performed to rule out recurrence when the patients had suspicious symptoms or signs. | 1 year |
| Total procedure time | Procedure time (in minutes) was defined as the interval from the beginning of local anesthesia to extraction of all femoral venous sheaths at the end of the procedure. Total ablation time was calculated in seconds but time for tentative ablation was not taken into account. | one day |
| Fluoroscopy time | 2. Fluoroscopy time (in minutes) was defined as thetotal duration of exposure during the procedure. | one day |
| 23750689 | Background | Wang Y, Patel D, Wang DW, Yan JT, Hsia HH, Liu H, Zhao CX, Zuo HJ, Wang DW. beta1-Adrenoceptor blocker aggravated ventricular arrhythmia. Pacing Clin Electrophysiol. 2013 Nov;36(11):1348-56. doi: 10.1111/pace.12196. Epub 2013 Jun 10. |
| 22875320 | Background | Lim PB, Robb D, Lambiase PD. Electrophysiology and ablation of arrhythmias. Br J Hosp Med (Lond). 2012 Jun;73(6):312-8. doi: 10.12968/hmed.2012.73.6.312. |
| 20843630 | Background | Brown KR, Rzucidlo E. Acute and chronic radiation injury. J Vasc Surg. 2011 Jan;53(1 Suppl):15S-21S. doi: 10.1016/j.jvs.2010.06.175. Epub 2010 Sep 16. |
| 32013865 | Derived | Chen G, Wang Y, Proietti R, Wang X, Ouyang F, Ma CS, Yu RH, Zhao C, Ma K, Qiu J, Liu Q, Wang DW. Zero-fluoroscopy approach for ablation of supraventricular tachycardia using the Ensite NavX system: a multicenter experience. BMC Cardiovasc Disord. 2020 Feb 3;20(1):48. doi: 10.1186/s12872-020-01344-0. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |