Impact of Catheter Stability on the Outcomes With Very High Power Short Duration Ablation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- First-pass isolation rate
研究概览
简要总结
Background: Atrial fibrillation (AF), the most common cardiac rhythm disorder can be treated with pulmonary vein isolation (PVI). One technique for PVI is point-by-point radiofrequency ablation. Very high power short duration ablation is one of the most advanced technologies for radiofrequency ablation. However, acute efficacy results with this technology vary in a wide range. Improvements in automated tagging modules, incorporating tracking of cardiac and respiratory motion and enhanced stability algorithms, may allow for a better assessment of lesion quality and location and may improve the so called first-pass isolation rate (an indicator for acute procedural efficacy).
Objective: To assess the acute procedural outcomes of very high power short duration PVI with the new enhanced stability software.
Methods: Investigator-initiated, prospective, single-arm study on one hundred symptomatic patients with paroxysmal AF will undergo PVI with the QDOT catheter using a power setting of 90W(QMODE+). The inter-tag distance will be 6 mm posteriorly and 4 mm anteriorly, and the enhanced stability algorithm will be used in all cases. After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. Primary endpoint will be first-pass isolation rate. Secondary outcomes are as follows: procedure time, left atrial dwell time, RF time, number of RF tags, use of a steerable sheath, occurrence of serious adverse events.
Hypothesis: Very high power short duration PVI using the new stability software results in a higher rate of first-pass isolation than previously published.
详细描述
Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in adults. Its prevalence increases with age, affecting 3/100 people, and its incidence is also correlated with age, affecting 30/100.000 people per year. Its clinical significance stems from common complications (stroke, heart failure) and concomitant higher mortality. The most effective rhythm control treatment method for atrial fibrillation is catheter ablation, which seeks to maintain sinus rhythm. Isolation of the triggering pulmonary veins (PVI) from the left atrium is the cornerstone of AF ablation. PVI has undergone significant technical development over the past decade; however, the chances of arrhythmia recurrence and the occurrence of procedural complications are not negligible. Experiments have shown that lesions with a slightly smaller surface diameter and less depth develop during high power short duration (HPSD) ablation. The shorter ablation time might result in more consistent lesion creation if the catheter stability is good during the radiofrequency (RF) application. On the other hand, if the catheter position is unstable during the RF application, a huge variety might occur between the created lesion sizes. Regarding the safety aspects, the shallower lesions might cause less damage to the surrounding tissues. The latest application of HPSD technology is the so-called "very high power short duration" (vHPSD) ablation with application of 90W power for 3-4 seconds. The ablation index does not work for such a short ablation time; thus, other lesion-predicting parameters should be used, such as impedance drop and catheter stability. At the moment, there are two software products for ablation point visualization. The commercially available legacy software was originally built to assess catheter stability over a long ablation period (e.g. with the ablation index), but the system is unable to differentiate between poor and good catheter stability during a 4 seconds time frame. Conversely, the new SVTAG software is adapted to assess catheter stability over a 4-second period; thus, the operator might get better feedback on the actual lesion creation. This might result in a more optimized lesion set and a more effective PVI, but this hypothesis has not been tested yet.
Objective: To evaluate the acute efficacy of radiofrequency PVI performed with 90W, using the new stability software version.
Primary hypothesis: Pulmonary vein isolation is effective with the Svtag software that gives proper feedback on catheter stability, resulting in short procedures, high first-pass isolation rate, and few acute reconnections.
Study Design: Multicenter, prospective, single-arm study.
Research period: The planned research period starts in the first quarter of 2023 until December 2025.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Symptomatic paroxysmal or persistent AF
- •Age >18 years
- •Willingness to sign the informed consent form
排除标准
- •Contraindication to ablation
- •Contraindication of long-term anticoagulation
- •Long-standing persistent AF
- •History of PVI
- •History of cardiac surgery
- •Pregnancy
- •Active malignancy
- •Life expectancy <1 year
- •Valvular AF
- •Reversible cause of AF (e.g. hyperthyroidism).
研究组 & 干预措施
SVtag arm. Point-by-point PVI with the Svtag software
PVI will be performed with QDot Micro catheter in QMODE plus with the Svtag software.
干预措施: Point-by-point PVI with the QDot Micro catheter in QMODE+ setting with the Svtag software (Device)
结局指标
主要结局
First-pass isolation rate
时间窗: Endpoint is assessed intra-procedurally
After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. If PVI is complete, this is defined as first-pass isolation. If PVI is not complete at this point, touch-up lesions will be delivered to reach the isolation of all pulmonary veins.
次要结局
- Acute reconnection(Assessed 20 minutes after PVI is reached during the procedure)
- 12-months AF freedom(12-month from procedure)
- Complications or adverse events(1 month)