Suction Device for Control and Accuracy of Transseptal Access

用于控制和精确进行房间隔进入的抽吸装置

• 批准号: 9346212
• 负责人: GHASSAN S KASSAB
• 金额: $ 80.86万
• 依托单位: 3DT HOLDINGS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9346212
• 关键词: Ablation; Address; Age; Animal Model; Animals; Area; Atrial Fibrillation; Award; Cadaver; Catheters; Chronic; Clinical; Clip; Comorbidity; Data; Data Collection; Device Removal; Device Safety; Devices; Diagnostic; Drops; Eligibility Determination; Europe; Excision; Feasibility Studies; Fossa; Heart; Heart Atrium; Human; Impairment; Implant; Implantation procedure; Inferior; Institutes; Institutional Review Boards; Intervention; Investigation; Lead; Learning; Left; Left Ventricular Function; Location; Mission; Mitral Valve Insufficiency; Movement; Multicenter Studies; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Neurological Disorders and Stroke; Operative Surgical Procedures; Patent Foramen Ovale; Pathology; Patient-Focused Outcomes; Patients; Perforation; Performance; Phase; Pilot Projects; Pliability; Positioning Attribute; Preparation; Procedures; Puncture procedure; Research; Risk; Roentgen Rays; Safety; Savings; Site; Slide; Small Business Innovation Research Grant; Suction; Surface; Techniques; Technology; Testing; Therapeutic; Thick; Time; Translating; United States National Institutes of Health; Vacuum; Validation; arm; auricular appendage; clinical efficacy; clinically relevant; commercialization; experience; good laboratory practice; human data; imaging modality; implantation; improved; in vivo; man; novel; phase 2 study; preclinical study; repaired; safety and feasibility; tool; virtual

ABSTRACT Transseptal (TS) access for left heart procedures is an important and rapidly growing area for diagnostics and therapy delivery with an expected total of over 10 million U.S. patients. In the U.S. and Europe, TS access procedures are used for atrial fibrillation ablation, left atrial appendage occlusion and patent foramen ovale closure as well as treatment of mitral valve regurgitation with the MitraClip (MC). Catheter positioning and device placement for MC has been challenging even for the most experienced interventionalist cardiologists (ICs) and has led to long procedure times with significant x-ray exposure. This emerging therapy necessitates a higher level of catheter stability and control over accuracy during puncture of the fossa ovalis (FO). If the initial puncture is inaccurate, delivery of therapy is virtually impossible which often requires removal, re-engagement and device re-advancement. Thus, initial localization and stabilization on the FO is critical for MC procedures to limit delivery times and x-ray exposure. Additionally, the presence of aneurysmal or fibrotic FO and the constant movement of the heart makes standard TS access puncture unpredictable and contributes to increased risk for atrial or aortic perforation. To overcome these limitations, we have developed and validated the performance and utility of a novel transseptal access catheter (TSAC) that utilizes vacuum suction technology to provide improved catheter localization and stabilization of the FO. The results of our preclinical studies were highly successful and support that through stabilization of the FO (4-fold reduction in puncture force), the TSAC reduces tenting (2.5-fold) to improve puncture accuracy (1.5-fold) compared to standard TS access devices in a clinically relevant animal model of mitral regurgitation. In this Phase II application, we propose an investigational device exemption (IDE) to conduct a human pilot study which will be used to assess primarily device safety and secondarily device feasibility in patients undergoing TS access for MC delivery. To accomplish these Phase II objectives, the following specific aims are proposed: 1) Final Animal Validation: To assess the safety of the TSAC in a set of animals under good-laboratory practice (GLP) conditions to be used for data submission to the FDA and institutional review boards (IRBs); and 2) Human Validation: To assess the contribution of human factors to feasibility in a small group of humans (36 patients) in a double-arm multi-center study. This Phase II study addresses a highly significant national and worldwide clinical need that can impact not just NHLBI, but many other mission areas of NIH. Successful completion of these proposed Aims will allow us to translate our research findings to a commercially available device that could drastically improve TS access procedures and hence, patient outcomes.

抽象的 左心手术的房间隔 (TS) 通路是一个重要且快速增长的诊断领域 预计将有超过 1000 万美国患者接受治疗。在美国和欧洲，TS 进入程序用于房颤消融、左心耳封堵和专利 卵圆孔闭合以及使用 MitraClip (MC) 治疗二尖瓣反流。导管 即使对于最有经验的人来说，MC 的定位和设备放置也充满挑战 介入心脏病专家 (IC) 的介入导致手术时间较长且 X 射线暴露较多。这 新兴疗法需要更高水平的导管稳定性和对穿刺过程中准确性的控制 卵圆窝 (FO)。如果最初的穿刺不准确，治疗实际上是不可能的，这通常是不可能的 需要移除、重新接合和装置重新前进。因此，初始定位和稳定 FO 上的信息对于 MC 程序来说至关重要，可限制交付时间和 X 射线暴露。此外，存在 动脉瘤或纤维化 FO 的发生以及心脏的持续运动使得 TS 通路穿刺成为标准 不可预测，并会增加心房或主动脉穿孔的风险。为了克服这些限制，我们 开发并验证了一种新型房间隔穿刺导管 (TSAC) 的性能和实用性，该导管 利用真空抽吸技术来改善 FO 的导管定位和稳定性。这 我们的临床前研究结果非常成功，并通过稳定 FO（4 倍 降低穿刺力），TSAC 减少隆起（2.5 倍）以提高穿刺精度（1.5 倍） 在临床相关的二尖瓣反流动物模型中与标准 TS 接入装置进行比较。在这个 第二阶段申请，我们提出研究设备豁免（IDE）以进行人体试点研究 它将用于主要评估设备安全性，其次评估设备在接受治疗的患者中的可行性 MC 传送的 TS 访问。为实现第二阶段目标，提出以下具体目标： 1) 最终动物验证：评估 TSAC 在良好实验室下的一组动物中的安全性 用于向 FDA 和机构审查委员会 (IRB) 提交数据的实践 (GLP) 条件； 2) 人类验证：评估人为因素对一小群可行性的贡献 一项双臂多中心研究中的人类（36 名患者）。这项二期研究解决了一个非常重要的问题 国家和世界范围内的临床需求不仅会影响 NHLBI，还会影响 NIH 的许多其他任务领域。 成功完成这些拟议目标将使我们能够将我们的研究成果转化为 商用设备可以极大地改善 TS 访问程序，从而改善患者 结果。