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临床试验/NCT02743325
NCT02743325已完成不适用

Optimisation of Catheter Navigation With As Low As Reasonable Achievable Fluoroscopy for Amelioration of Ablation Success in Patients With SupraVentricular Tachycardia (ALARA-SVT)

Richard Kobza0 个研究点目标入组 60 人开始时间: 2016年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
recurrence of arrhythmia documented by ECGs

研究概览

简要总结

Supraventricular tachycardia ablations of the Conformité Européenne (CE)-certified (since 2013) CartoUnivuTM module (Biosense Webster, Diamond Bar, USA) allows a seamless combination of a fluoro image and Carto® 3 System maps into a single view. This helps to reduce fluoroscopy levels and reduce exposure time for physicians, staff and patients to as low as reasonably achievable. The UnivuTM technology will be compared in a randomized manner to the conventional radiofrequency Ablation.

详细描述

Aim of the current Randomized Clinical Study is to assess the safety and efficiency in supraventricular tachycardia ablations of the CE-certified (since 2013) CartoUnivuTM module (Biosense Webster, Diamond Bar, USA), allowing a seamless combination of a fluoro Image and Carto® 3 System maps into a single view. It helps reduce fluoroscopy levels - consistent with the ALARA principle of reducing exposure for physicians, staff and patients to as low as reasonably achievable. The UnivuTM technology will be compared in a randomized manner to the conventional radiofrequency (RF) ablation.

Patients with symptomatic supraventricular tachycardia (SVT) will be included, more specifically patients with atrioventricular nodal re-entrant tachycardia (AVRNT), atrioventricular re-entrant tachycardia (AVRT) and typical atrial flutter (TAF). Current ablative treatment consists in destroying small areas of myocardial tissue or conduction system, or both, that are critical to the initiation or maintenance of the arrhythmia (slow pathway Ablation in the case of AVRNT, anomalous extra nodal connections between the atrium and ventricle along the atrioventricular groove in AVRT and cavo-tricuspid isthmus in the case of TAF).

However, SVT ablations without a 3D navigation system have a certain fluoroscopy time and radiation exposure, respectively. Prolonged fluoroscopy and radiation exposure during ablation may potentially cause an increase in the lifetime risk of fatal malignancy.

In a 1-year follow-up the arrhythmia recurrence rate without anti-arrhythmic drugs will be assessed using 7-day holter recording in 60 patients undergoing CartoUnivuTM guided SVT ablation (group A) vs. 60 patients undergoing conventional RF-catheter ablation (without CartoUnivuTM, group B).

All patients will stop anti-arrhythmic drugs at least 1 week before the date of ablation. Each patient will undergo transthoracal echocardiography (TTE) before the intervention. In case transseptal is needed, heparin will be administered after successful transseptal puncture with an activated clotting time (ACT)-target ≥325 sec.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with symptomatic SVT undergoing first SVT ablation procedure (and no prior history of cardiac surgery
  • •Structurally normal heart (no major cardiac defects)

排除标准

  • •Previous ablation for SVT (or cardiac surgery)
  • •Contra-indications to catheter ablation therapy
  • •Congenital heart disease

研究组 & 干预措施

ALARA protocol

Active Comparator

SVT ablation by ALARA protocol

干预措施: SVT ablation by ALARA protocol (Procedure)

current treatment

Active Comparator

SVT ablation by conventional protocol

干预措施: SVT ablation by conventional protocol (Procedure)

结局指标

主要结局

recurrence of arrhythmia documented by ECGs

时间窗: within 90 days after the ablation procedure

Documentation by ECG,7-day-holter ECG, symptoms description by the patient

次要结局

  • Duration of Ablation procedure in minutes(skin to skin of the ablation procedure)
  • total fluoroscopy time in minutes(during the ablation procedure)
  • total radiation exposure in gy(during the ablation procedure)
  • Composite adverse events(within the first 30 days post ablation procedure)

研究者

发起方
Richard Kobza
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Richard Kobza

PD Dr. med.

Luzerner Kantonsspital

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