New generation of catheters for treatment of atrial fibrillation

新一代治疗心房颤动的导管

• 批准号: 10581410
• 负责人: Omar Amirana
• 金额: $ 99.9万
• 依托单位: LUXMED SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-14 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10581410
• 关键词: Ablation; Algorithms; Animal Model; Animal Testing; Animals; Arrhythmia; Atrial Fibrillation; Australia; Authorization documentation; Cardiac; Cardiac ablation; Caring; Catheters; Chest; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collagen; Complex; Contracts; Data Set; Detection; Development; Devices; Documentation; Ensure; Family suidae; Feedback; Fiber; Financial Support; Funding; Generations; Health; Heart; Heart Atrium; Hospitals; Human; Image; Indiana; Knowledge; Lesion; Location; Maps; Medical; Metabolic; Monitor; Morbidity - disease rate; Movement; Myocardial tissue; NADH; Names; Optics; Output; Percutaneous Catheter Ablation; Performance; Pharmaceutical Preparations; Phase; Physicians; Preparation; Procedures; Pulmonary veins; Quality of life; Radiofrequency Interstitial Ablation; Recording of previous events; Recurrence; Regimen; Reporting; Resolution; Rest; Safety; Secure; Series; Site; Small Business Technology Transfer Research; Source; Stroke; Surface; System; Technology; Testing; Therapeutic; Thromboembolism; Time; Tissues; Touch sensation; UV sensitive; Ultraviolet Rays; United States National Institutes of Health; Update; Validation; Veins; Visualization; clinic ready; commercialization; data acquisition; design; diagnostic algorithm; experimental study; first-in-human; healing; heart damage; hemodynamics; human study; improved; instrument; instrumentation; manufacture; meetings; mortality; new technology; novel diagnostics; porcine model; pre-clinical; product development; radio frequency; real time monitoring; response; safety testing; tissue injury

ABSTRACT Atrial fibrillation (AF) remains the most commonly occurring cardiac arrhythmia. It is associated with a lower quality of life and a higher rate of morbidity and mortality primarily due to poor hemodynamic performance and often stroke. One of the primary options to treat AF is cardiac ablation where the physician applies radiofrequency energy via percutaneous catheters to form a series of lesions that directly destroys or isolates abnormal sources of electrical activity. Specific to AF ablation, a series of lesions are created to encircle the pulmonary veins forming an electrical barrier that isolates the arrhythmogenic foci inside the vein from the rest of the heart. However, while attempting to form lesion sets, the physician inadvertently leaves viable gaps that can be extremely difficult to detect, especially when the tissue is electrically stunned but remains metabolically viable. When this happens, these gaps will heal over time and reconduct the abnormal electrical activity to the rest of the heart, causing high post-procedural recurrence rates. As such, there is a strong clinical need to identify these gaps. Unfortunately, to date there are limited means for real-time monitoring of tissue injury and gap detection during ablation procedures and there are no means of directly detecting permanently damaged cardiac tissue. Here we propose to commercialize a new generation of percutaneous catheters that can distinguish viable from ablated cardiac tissue by sensing, in real time, spectral changes in tissue autofluorescence profiles caused by thermal damage. During the Phase II we produced and tested in live animals two versions of catheters, one that acquires an optical signature from a single fiber at the point where catheter tip touches the tissue, and a more complex version capable of hyperspectral imaging. This Phase IIB proposal seeks NIH funding to help commercialize the first optically enabled therapeutic ablation catheters under the trade name OmniView™. The first major task of the proposal to do so will be to manufacture 270 catheters and 20 instruments to be used for V&V testing and the subsequent clinical trial. These catheters and the instruments will undergo extensive V&V safety testing based upon standards outlined in the proposal. GLP live animal testing will be conducted in the large-animal porcine model. Following successful V&V testing, we will prepare an Investigational Device Exemption document set for submission to the FDA in order to receive permission to begin the clinical trial. We have identified five hospital sites with highly regarded electrophysiologists who are eager to participate. We have also held initial meetings with the FDA to obtain feedback on clinical strategy and have identified a CRO for clinical trial oversight. We will then perform the clinical trial as the key step towards commercialization. In summary, there remains an unmet clinical need for a system that can distinguish, in real-time, healthy versus ablated myocardial tissue with high resolution in order to identify and ablate gaps between lesions. Our new generation of percutaneous catheters and instruments is capable of acquiring tissue autofluorescence profiles during the ablation procedure therefore assisting physicians in providing better care.

抽象的 心房颤动（AF）仍然是最常见的心律失常。它与较低的 生活质量以及较高的发病率和死亡率主要是由于血流动力学性能差和 经常中风。治疗 AF 的主要选择之一是心脏消融术，即医生应用射频 通过经皮导管产生能量，形成一系列病灶，直接破坏或隔离异常源 的电活动。具体到 AF 消融，会产生一系列围绕肺静脉的病变 形成电屏障，将静脉内的致心律失常病灶与心脏的其他部分隔离。 然而，在尝试形成病变组时，医生无意中留下了可被修复的可行间隙。 极难检测，特别是当组织被电击晕但仍具有代谢活力时。 当这种情况发生时，这些间隙会随着时间的推移而愈合，并将异常的电活动重新传导到其余部分 心脏，导致术后复发率高。因此，临床上迫切需要识别这些 差距。不幸的是，迄今为止，实时监测组织损伤和间隙检测的手段有限 在消融过程中，没有办法直接检测永久性受损的心脏组织。 在这里，我们建议将新一代经皮导管商业化，该导管可以区分活细胞和活细胞 通过实时感测组织自发荧光轮廓的光谱变化来消融心脏组织 热损伤。在第二阶段，我们生产了两种版本的导管并在活体动物中进行了测试，其中一种 在导管尖端接触组织的点处从单根光纤获取光学特征，并且更多 能够进行高光谱成像的复杂版本。该 IIB 阶段提案寻求 NIH 资金来帮助 将第一个光学治疗消融导管商业化，商品名为 OmniView™。这 该提案的首要任务是制造 270 根导管和 20 种器械，用于 V&V 测试和随后的临床试验。这些导管和仪器将接受广泛的 V&V 根据提案中概述的标准进行安全测试。 GLP 活体动物测试将在 大型动物猪模型。成功进行 V&V 测试后，我们将准备一个研究设备 准备向 FDA 提交豁免文件以获得开始临床试验的许可。我们 已经确定了五个拥有渴望参与的备受尊敬的电生理学家的医院地点。我们有 还与 FDA 举行了初步会议，以获得有关临床策略的反馈，并确定了 CRO 临床试验监督。然后我们将进行临床试验，作为商业化的关键一步。在 总之，对于能够实时区分健康与健康的系统的临床需求仍然未得到满足 以高分辨率消融心肌组织，以识别和消融病变之间的间隙。我们的新 新一代经皮导管和仪器能够获取组织自发荧光图谱 在消融过程中，因此可以协助医生提供更好的护理。