Background and purpose

Saline-irrigated radiofrequency ablation (RFA) for atrial fibrillation (AF) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration. The DiamondTemp (DT) ablation catheter was designed to allow efficient temperature-controlled irrigated ablation. We sought to assess the 1-year clinical safety and efficacy of the DT catheter in treating drug-refractory paroxysmal AF.

Methods

The TRAC-AF trial (NCT02821351) is a prospective, multi-center (n = 4), single-arm study which enrolled patients with symptomatic, drug-refractory, paroxysmal AF. Using the DT catheter, point-by-point ablation was performed around all pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was performed in a temperature-controlled mode (60 °C, max 50 W). Acute and chronic efficacy and safety was evaluated.

Results

Seventy-one patients (age 69.9 ± 11.0 years; 60.6% male) were ablated using the DT catheter. The mean fluoroscopy and RF ablation times were 9.3 ± 6.1 min and 20.6 ± 8.9 min, respectively. Acute isolation of all PVs was achieved in 100% of patients, and freedom from AF after 1 year was 70.6%. There were no steam pops, char, or coagulum on the catheter tip after ablation. There were few serious procedure/device-related adverse events including a single case of cardiac tamponade (1.4%) and transient ischemic attack (1.4).

Conclusion

This first in man series demonstrates that temperature-controlled irrigated RFA with the DT catheter is efficient, safe, and effective in the treatment of paroxysmal AF. Randomized controlled trials are ongoing and will evaluate better the role of this catheter in relation to standard RFA.

Trial registration

Registered on the site ClinicalTrials.gov January 2016 with identifier: NCT02821351

中文翻译：

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新型温控射频消融系统在阵发性房颤患者肺静脉隔离期间的疗效和安全性：TRAC-AF 研究

背景和目的

用于房颤 (AF) 的盐水冲洗射频消融 (RFA) 受到缺乏可靠热反馈的限制，从而限制了温度监测在功率滴定中的应用。DiamondTemp (DT) 消融导管旨在实现高效的温控灌溉消融。我们试图评估 DT 导管治疗药物难治性阵发性 AF 的 1 年临床安全性和有效性。

方法

TRAC-AF 试验 (NCT02821351) 是一项前瞻性、多中心 ( n = 4) 单臂研究，纳入了有症状、药物难治性、阵发性 AF 的患者。使用 DT 导管，在所有肺静脉 (PV) 周围进行逐点消融，以实现 PV 隔离 (PVI)。消融在温度控制模式下进行（60 °C，最大 50 W）。评估了急性和慢性疗效和安全性。

结果

71 名患者（年龄 69.9 ± 11.0 岁；60.6% 男性）使用 DT 导管消融。平均透视和射频消融时间分别为 9.3 ± 6.1 分钟和 20.6 ± 8.9 分钟。100% 的患者实现了所有 PV 的急性隔离，1 年后无 AF 为 70.6%。消融后导管尖端没有蒸汽爆裂、炭化或凝结物。几乎没有严重的手术/器械相关不良事件，包括单例心脏压塞（1.4%）和短暂性脑缺血发作（1.4）。

结论

这是人类系列中的第一个，表明使用 DT 导管的温控冲洗 RFA 在治疗阵发性 AF 方面是有效、安全和有效的。随机对照试验正在进行中，并将更好地评估该导管相对于标准 RFA 的作用。

试用注册

2016 年 1 月在 ClinicalTrials.gov 网站上注册，标识符为：NCT02821351