背景:尽管治疗室性心动过速(VT)的技术和技术在不断发展,目前对于室性心动过速管理的临床试验仍未得到充分研究.
目的:本研究的目的是通过对ClinicalTrials.gov,临床试验登记。欧盟,anzctr.org.auandchictr.org.cn数据库。
方法:我们查询了截至2023年11月登记的所有II至IV期介入试验,这些试验纳入了室性心动过速患者。已发布,已完成但未发表,已终止,或纳入正在进行的试验进行最终分析.
结果:在698项注册研究中,135与VT有关,123项试验纳入最终分析.在这些试验中,25(20%)已发布,在中位数为43个月(IQR19-62)期间,纳入中位数为35名患者(四分位距[IQR]20-132)。在公布的试验中,14人(56%)被随机分组,12例(48%)集中于导管消融.二十二(18%)已完成,但仍未发布,即使经过36个月的中位数(IQR15-60)。此外,27项(22%)试验被终止或撤回,最常见的原因是入学率低。目前,49项(40%)试验正在进行中,是新的非消融技术,如放射消融和自主调制,占正在进行的试验的35%和8%,分别。
结论:我们的分析表明,许多已注册的试验仍未发表或不完整,随机对照试验证据仅限于少数研究。此外,许多正在进行的试验都集中在基于非导管消融的策略上.因此,未来需要更大规模的务实试验来创造更有力的证据.
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 Published, completed but unpublished, terminated, or ongoing trials were included for final analysis.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 Twenty-two (18%) have been completed but remain unpublished, even after a median of 36 months (IQR 15-60). Furthermore, 27 (22%) trials were terminated or withdrawn, with the most common cause being poor enrolment.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CONCLUSIONS: Our analysis revealed that many registered trials remain unpublished or incomplete, and randomised controlled trial evidence is limited to only a few studies.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.