An interventional study of Zero-fluoroscopic ablation and Conventional fluoroscopic ablation in Paroxysmal Supraventricular Tachycardia, sponsored by Tongji Hospital. Completed at 1 site in China. Open to participants aged 12 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment
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.
443 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's enrollment of 3,060 is above the median of 64 across 269 interventional studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →Tongji Hospital is the lead sponsor of 384 studies on the registry; 208 are open to participants now.
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Exclusion Criteria:
Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy.
Device: Zero-fluoroscopic ablation
Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.
Device: Conventional fluoroscopic ablation
Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.
Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.
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.
Time frame: one year
Complications
Complications were defined as pseudoaneurysm, arterialvenous fistula, pneumothorax, second- or third-degree atrioventricular block, cardiac tamponade, or other serious complications requiring intervention.
Time frame: one year
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.
Time frame: 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.
Time frame: 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.
Time frame: one day
Fluoroscopy time
2\. Fluoroscopy time (in minutes) was defined as thetotal duration of exposure during the procedure.
Time frame: one day
Plan to share: No
The record gives a start of Jan 2012, a primary completion of Feb 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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