Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

Paroxysmal Supraventricular Tachycardia Clinical Trial

— ZFA-PSVT  

Official title:

Multi-center, Controlled Trial to Compare the Feasibility, Safety and Efficacy of Zero-fluoroscopic Approach With Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042078
• Other study ID #: TJHCDD-ZF-PSVT-20140301
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2018

Study information

• Verified date: November 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3060
• Est. completion date: December 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 90 Years

Eligibility

Inclusion Criteria:

• Atrioventricular Nodal Reentrant Tachycardia
• Atrioventricular Reentrant Tachycardia

Exclusion Criteria:

• Atrial Tachycardia
• Organic supraventricular tachycardia

Related Conditions & MeSH terms

• Paroxysmal Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular

Intervention

Device:
• Zero-fluoroscopic ablation
Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.
• Conventional fluoroscopic ablation
Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (9)

Lead Sponsor	Collaborator
Tongji Hospital	Beijing Anzhen Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Morristown Memorial Hospital, Ningbo No. 1 Hospital, Xiangyang Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. Erratum In: J Vasc Surg. 2012 Feb;55(2):627. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Immediate 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 day
Secondary	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
Secondary	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
Secondary	Fluoroscopy time	2. Fluoroscopy time (in minutes) was defined as thetotal duration of exposure during the procedure.	one day