Eliminating Ventricular Tachycardia: Pivotal Clinical Trial using the Durablate® Catheter

消除室性心动过速：使用 Durablate® 导管的关键临床试验

• 批准号: 10762302
• 负责人: MICHAEL G CURLEY
• 金额: $ 134.23万
• 依托单位: THERMEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-12 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10762302
• 关键词: 3-Dimensional; Ablation; Acute; Affect; Agreement; Aneurysm; Anti-Arrhythmia Agents; Arrhythmia; Award; Breakthrough device; Cardiac; Cardiac Volume; Cardiovascular system; Catheters; Cessation of life; Characteristics; Chronic; Circulation; Clinical; Clinical Research; Clinical Trials; Communities; Convection; Defibrillators; Development; Devices; Dimensions; Electrophysiology (science); Eligibility Determination; Etiology; Event; FDA approved; Funding; Goals; Guidelines; Healthcare Systems; Heart Atrium; Image; Implant; Implantable Defibrillators; Incidence; Infarction; Ischemia; Lesion; Life; Life Expectancy; Liver neoplasms; Location; Magnetic Resonance Imaging; Maps; Mechanics; Medicare; Medicare/Medicaid; Methods; Modernization; Monitor; Myocardium; Pain; Patients; Perforation; Persons; Pharmaceutical Preparations; Physicians; Primary Prevention; Procedures; Publishing; Quality of life; Radiofrequency Interstitial Ablation; Recurrence; Refractory; Safety; Saline; Shock; Small Business Innovation Research Grant; Sterility; Stroke; Supraventricular tachycardia; Surface; System; Tachycardia; Techniques; Technology; Thermal Ablation Therapy; Thermal Conductivity; Tissues; United States; United States National Institutes of Health; Validation; Ventricular; Ventricular Arrhythmia; Ventricular Tachycardia; arm; biomaterial compatibility; care costs; cost; curative treatments; editorial; effusion; experience; first-in-human; human study; implantation; improved; patient population; prevent; reconstruction; research clinical testing; response; safety testing; standard of care; structural heart disease; success; sudden cardiac death; symposium; tool

Ventricular tachycardia (VT) causes more than half of the 170,000–450,000 sudden cardiac deaths (SCD) that occur annually in the United States. Implantable cardioverter defibrillators (ICDs) are the standard of care, but they are expensive (the total cost of an ICD implant exceeds $50,000) and not curative. Patients who receive ICDs are subject to shocks to halt episodes of VT, and those shocks can be painful and traumatic. RF ablation represents a potential method for curing VT, at a much lower cost than ICDs, but while RF ablation has been successful at treating atrial arrhythmias, it is not as effective at treating VT. An ablation tool capable of treating VT has the potential to improve ICD therapy by eliminating shocks or even the need for ICD implants, greatly reducing the cost to the health care system of treating VT while also improving the lives of patients affected by VT. Recent advances in 3-D reconstruction of CT or MRI images and with merging those images with electroanatomic maps have made identification of the tissue that needs to be ablated easier. We have developed the ablation tool that can reliably treat all VT foci. We have developed the Durablate® Catheter and SERF ablation specifically the treatment of VT. Our technology delivers heated saline along with RF energy and is unique in its ability to treat the large volumes of cardiac tissue necessary to eliminate arrhythmogenic tissue located either on the endocardial surface or deep in the ventricular wall. Our technology can treat much larger volumes of tissue than conventional RF because saline carries the heat generated by RF into tissue by convection. We also have fine control over the size of the ablated lesion since we have control over the amount of saline delivered. SERF lesions can be as small or as large as the physician needs and they will be the size the physician calls for. We have successfully concluded a small first-in-human study whose results were recently published in Circulation: Arrhythmia and Electrophysiology. An accompanying editorial described the results as “impressive” in a patient population with “clinical characteristics that would intimidate even the most optimistic and experienced VT ablation enthusiasts.” The FDA has awarded our technology Breakthrough Device Designation and has approved our IDE for our pivotal clinical trial. We will conduct the 154-patient single-arm study at seven centers. Patients will be eligible for the study if they have recurrent, symptomatic VT; if they have failed prior cardiac catheter VT ablation; if the etiology of the arrhythmia is related to structural heart disease; or if a target arrhythmia has been treated by an implanted ICD. Successful completion of this clinical trial will result in the US clearance for the Durablate catheter and will offer an underserved patient population a better quality of life and the possibility of a cure.

室性心动过速（VT）是造成17万- 45万例心脏骤停的一半以上原因