Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Interventions
- Device: Zero-fluoroscopic ablationDevice: Conventional fluoroscopic ablation
- Registration Number
- NCT03042078
- Lead Sponsor
- Tongji Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3060
- Atrioventricular Nodal Reentrant Tachycardia
- Atrioventricular Reentrant Tachycardia
- Atrial Tachycardia
- Organic supraventricular tachycardia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zero-fluoroscopic ablation Zero-fluoroscopic ablation Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX and without the use of fluoroscopy. Conventional fluoroscopic ablation Conventional fluoroscopic ablation Paroxysmal supraventricular tachycardia will be ablated under the guidance of Ensite NavX plus fluoroscopy.
- Primary Outcome Measures
Name Time Method Procedural success rate one year 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.
- Secondary Outcome Measures
Name Time Method Complications one year Complications were defined as pseudoaneurysm, arterialvenous fistula, pneumothorax, second- or third-degree atrioventricular block, cardiac tamponade, or other serious complications requiring intervention.
Immediate success rate one day 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.
Recurrence Rate 1 year 2. An ECG and electrophysiology study would be performed to rule out recurrence when the patients had suspicious symptoms or signs.
Total procedure time one day 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.
Fluoroscopy time one day 2. Fluoroscopy time (in minutes) was defined as thetotal duration of exposure during the procedure.
Trial Locations
- Locations (1)
Tongji Hospital
🇨🇳Wuhan, Hubei, China