The Current Landscape of Ventricular Tachycardia Trials: A Systematic Review of Registered Studies

IF 2.2 4区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Heart, Lung and Circulation Pub Date : 2024-08-01 DOI:10.1016/j.hlc.2024.01.041
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Abstract

Background

Although there are evolving techniques and technologies for treating ventricular tachycardia (VT), the current landscape of clinical trials for managing VT remains understudied.

Objective

The objective of this study was to provide a systematic characterisation of the interventional management of VT through an analysis of the ClinicalTrials.gov, clinicaltrialsregister.eu, anzctr.org.au and chictr.org.cn databases.

Methods

We queried all phase II to IV interventional trials registered up to November 2023 that enrolled patients with VT. Published, completed but unpublished, terminated, or ongoing trials were included for final analysis.

Results

Of the 698 registered studies, 135 were related to VT, with 123 trials included in the final analysis. Among these trials, 25 (20%) have been published, enrolling a median of 35 patients (interquartile range [IQR] 20–132) over a median of 43 months (IQR 19–62). Out of the published trials, 14 (56%) were randomised, and 12 (48%) focused on catheter ablation. Twenty-two (18%) have been completed but remain unpublished, even after a median of 36 months (IQR 15–60). Furthermore, 27 (22%) trials were terminated or withdrawn, with the most common cause being poor enrolment. Currently, 49 (40%) trials are ongoing and novel non-ablative technologies, such as radioablation and autonomic modulation, account for 35% and 8% of ongoing trials, respectively.

Conclusions

Our analysis revealed that many registered trials remain unpublished or incomplete, and randomised controlled trial evidence is limited to only a few studies. Furthermore, many ongoing trials are focused on non-catheter ablation-based strategies. Therefore, larger pragmatic trials are needed to create stronger evidence in the future.

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室性心动过速试验的现状:注册研究的系统性回顾。
背景:尽管治疗室性心动过速(VT)的技术和科技在不断发展,但目前治疗 VT 的临床试验情况仍未得到充分研究:本研究的目的是通过分析 ClinicalTrials.gov、clinicaltrialsregister.eu、anzctr.org.au 和 chictr.org.cn 数据库,对 VT 的介入治疗进行系统描述:我们查询了截至 2023 年 11 月注册的所有纳入 VT 患者的 II 至 IV 期介入性试验。最终分析纳入了已发表、已完成但未发表、已终止或正在进行的试验:在登记的 698 项研究中,135 项与 VT 相关,其中 123 项纳入最终分析。在这些试验中,有 25 项(20%)已发表,入组患者中位数为 35 人(四分位数间距 [IQR] 20-132),入组时间中位数为 43 个月(IQR 19-62)。在已发表的试验中,14 项(56%)是随机试验,12 项(48%)侧重于导管消融。有 22 项(18%)试验已经完成,但仍未发表,即使中位数为 36 个月(IQR 15-60)。此外,有 27 项(22%)试验被终止或撤销,最常见的原因是入选率低。目前,有49项(40%)试验正在进行中,而新型非消融技术,如放射性消融和自主神经调节,分别占正在进行的试验的35%和8%:我们的分析表明,许多已登记的试验仍未公布或不完整,随机对照试验的证据也仅限于少数几项研究。此外,许多正在进行的试验都集中在非导管消融策略上。因此,未来需要更大规模的实用性试验来提供更有力的证据。
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来源期刊
Heart, Lung and Circulation
Heart, Lung and Circulation CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
4.50
自引率
3.80%
发文量
912
审稿时长
11.9 weeks
期刊介绍: Heart, Lung and Circulation publishes articles integrating clinical and research activities in the fields of basic cardiovascular science, clinical cardiology and cardiac surgery, with a focus on emerging issues in cardiovascular disease. The journal promotes multidisciplinary dialogue between cardiologists, cardiothoracic surgeons, cardio-pulmonary physicians and cardiovascular scientists.
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