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The research division of the Department of Advanced Cardiopulmonary Therapies and Transplantation oversees more than 50 clinical trial protocols. Our program offers investigational and cutting-edge therapies for your patients, especially those who are high risk or not eligible for conventional approved cardiac therapies. Our goal is to offer a clinical trial to any patient who walks through our door and will benefit from it. Our research efforts include both principal investigator-led studies and clinical partnerships with many different sponsors. We are currently actively enrolling patients in clinical trials in the field of structural heart, heart failure, surgical LVAD, and percutaneous LVAD as part of our daily practice. Our department is also proud to host The VAD Journal, a dynamic, multidisciplinary, peer-reviewed forum for all subspecialties in the field of mechanical-assisted circulation and advanced heart failure. The journal enables the rapid dissemination of unbiased clinical research and observations.
Our goal is to have a clinical trial for every patient that has exhausted currently approved therapies. For more information please email us atHFResearch@uth.tmc.edu。
Currently, we are enrolling patients in the current临床试验:
结构性心脏病临床试验
爱德华兹·帕斯卡（Edwards Pascal）经导管阀修复系统关键试验（CLASP II TR）
Tricuspid Regurgitation (TR) is a condition in which the heart’s tricuspid valve does not close tightly, which causes blood to flow backwards in the incorrect direction during part of the cardiac cycle. This condition increases the workload on the heart, and if left untreated, it can increase the risk of worsening heart failure. The tricuspid valve has three leaflets. The device implant will be positioned to grasp each of these leaflets and bring them together to help reduce the leak in the valve. The PASCAL implant will act as a filler to help reduce abnormal backflow of blood in the heart.
For more information:https://www.clinicaltrials.gov/ct2/show/NCT04097145
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)
该试验的目的是评估一种称为Tendyne™二尖瓣系统的新研究设备。Tendyne二尖瓣系统设计用于治疗患病，受损或故障的二尖瓣。该试验将收集有关该设备与市售（由美国食品药品监督管理局（FDA）批准）Mitraclip®系统相比，该设备处理泄漏的二尖瓣的安全性。Mitraclip系统由一个递送导管和一个可植入的夹子组成，旨在通过将两个小叶夹在一起来修复二尖瓣。该试验将包括中度至重度或重度二尖瓣的患者，由于二尖瓣沉积大量钙沉积而导致的米特拉拉普治疗以及有症状二尖瓣疾病的患者。这些患者将通过锥形二尖瓣系统进行治疗，并将收集信息，以评估该设备在这些患者中的安全性和功效。
For more information:https://www.clinicaltrials.gov/ct2/show/NCT03433274
SAPIEN™M3系统经导管二尖瓣通过转换访问替换（Oncircle）
This is a prospective single-arm, multicenter and adaptive design study. The objective of this study is to establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ MR for whom commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
For more information:https://clinicaltrials.gov/ct2/show/NCT04153292
随机分配到Evolut™或Sapien™试验（SMART）的小型Annuli
This is a prospective, multi‐center, international, randomized controlled, post‐market
trial. The purpose of this trial is to generate clinical evidence on valve safety and performance of self‐expanding (SE) versus balloon‐expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+ System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure. Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV).
For more information:https://clinicaltrials.gov/ct2/show/nct04722250
心脏移植的临床试验
Surveillance HeartCare® Outcomes Registry (SHORE)
该注册表的目的是观察由心脏保健管理的心脏移植接受者的结果。这是通过收集有关您的心脏移植的信息，例如测试结果，活检结果和结果，将这些信息存储在数据库中，以及使用该信息进行研究来完成。beplay苹果手机能用吗为了本研究的目的，将收集额外的血液。美国食品药品监督管理局（FDA）已清除Allomap®血液测试，自2005年以来可供使用。Allomap测量血液中20个基因的水平。您的移植团队使用Allomap测试分数以及其他标准测试，以了解您的身体接受新心脏的程度。Allosure-Heart®是另一种血液检查，评估了移植的心脏受伤。发生损伤时，将一种称为供体衍生的无细胞DNA（DD-CFDNA）的特殊类型的DNA释放到您的血液中。同盟心脏测量血液中DD-CFDNA的量。Allosure Heart提供的信息可以帮助您的主要医疗保健提供者确定适合您的治疗方法。
For more information:https://www.clinicaltrials.gov/ct2/show/NCT03695601
介入性心力衰竭临床试验
Reducing Lung Congestion Symptoms Using the V-Wave Shunt in Advanced Heart Failure (RELIEVE HF)
某些类型的心脏衰竭会导致retention of extra fluid that causes an increase in the pressure on the left side of the heart. The increased pressure leads to congestion in the lungs. Common symptoms of heart failure can be due to the extra fluid or congestion and include shortness of breath, fatigue, and swelling of the feet or legs. The study shunt (V-Wave Interatrial Shunt) is implanted in the dividing wall (septum) between the right and left atria (top chambers) of the heart. The small opening in the center allows a small amount of blood to flow from the top left chamber to the top right chamber of the heart. By transferring or “shunting” this small amount of blood, the increased pressure in the left side of the heart is reduced, which is expected to reduce congestion in the lungs and improve symptoms of heart failure. These patients will be treated with the V-Wave Interatrial Shunrt and information will be collected for evaluating the safety and efficacy of this device in these patients.
For more information:https://www.clinicaltrials.gov/ct2/show/NCT03499236
A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (PROACTIVE HF)
This is a prospective, randomized, controlled, single blind, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients. The Cordella PA Sensor will be implanted in conjunction with a right heart catheterization (RHC) procedure and the device will be introduced via percutaneous venous access to the pulmonary artery.
For more information:https://clinicaltrials.gov/ct2/show/NCT04089059
Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)
The purpose of this research study is to evaluate a heart pressure sensor called the CardioMEMS™ PA Sensor (referred to as “the device”) within the CardioMEMS™ HF System. This small sensor is implanted into the heart on the tip of a catheter and through a vein to measure pulmonary artery pressure. The CardioMEMS™ HF System is approved by the U.S. Food and Drug Administration (FDA) for a select group of patients. The study will help to determine if using the device’s data for other indicators of heart failure may reduce heart failure related hospital-admissions. You may be eligible if you are at risk of having episodes of worsening heart failure.
For more information:https://www.clinicaltrials.gov/ct2/show/NCT03387813
Bioventrix Revivent TC™用于治疗左心室动脉瘤的临床研究（活着）
A Left Ventricular Aneurysm (LVA) is a large area of the left ventricle of the heart that is damaged and no longer ejects blood efficiently. An LVA may result from complications after a heart attack, physical trauma, cardiac disease, or a congenital heart defect. The Revivent TC System study is being conducted to test an investigational device designed to repair a LVA without the use of a heart-lung machine or opening the chest/heart chamber. The device works by placing a tuck in the heart where there is scar. This shortens the distance across the heart and decreases the tension, or stress, on the working heart muscle.
For more information:https://www.clinicaltrials.gov/ct2/show/NCT02931240
自主神经疗法以减少射血分数（Anthem HFREF）来增强心肌功能并降低心力衰竭的进展
ANTHEM-HFrEF is a multi-center, open-label, randomized controlled clinical trial with an adaptive design. Patients with symptomatic heart failure and reduced left ventricular ejection fraction will be enrolled and randomized 2:1 to receive VITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy (therapy), or to continue receiving stable guideline-directed medical therapy alone (control arm).
治疗组中的受试者将在完成手术后连续，周期性的VNS刺激，并在3个月的时间内接受VNS滴定的访问。控制臂中的受试者还将以类似于预定的治疗臂受试者的滴定访问的频率进行预定的访问。
For more information:https://clinicaltrials.gov/ct2/show/nct03425422
Mechanical Circulatory Support Clinical Trials
Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES)
The HeartMate 3 is a U.S. Food and Drug Administration (FDA) approved mechanical heart pump device that pumps blood when the heart cannot. The HeartMate 3 requires pharmaceuticals to keep blood from clotting (also known as “blood thinners,” anticoagulants, and antiplatelet medications). Two blood thinner pharmaceuticals are currently used with the HeartMate 3: aspirin and warfarin. This study is investigating the efficacy comparison between the combination of aspirin and warfarin, as compared to warfarin alone.
For more information:https://www.clinicaltrials.gov/ct2/show/nct04069156
ST拔出的心肌梗塞（STEMI-DTU）中的主要卸载和延迟再灌注
该研究将评估使用临时循环辅助装置（心脏泵）在心脏病发作治疗期间通过抽血来支撑心脏。该设备称为Impella®CP系统或带有Smartassist系统（“研究设备”）的Impella CP。该研究装置已获得美国食品药品监督管理局（FDA）在美国的商业用途批准，以治疗有不同条件的患者，并且需要帮助从心脏中泵入血液到人体其余部分。
For more information:https://www.clinicaltrials.gov/ct2/show/NCT03947619
Pulmonary Clinical Trials
A Study to Test the Efficacy and Safety of Inhaled TD139 in Subjects with Idiopathic Pulmonary Fibrosis (GALACTIC-1)
Galecto Biotech AB已开始对称为TD139的研究药物（也称为“研究药物”）的研究，是特发性肺纤维化（IPF）的可能治疗方法。这项研究的主要目的是了解研究药物的工作原理以及研究药物与安慰剂的比较。
For more information:https://www.clinicaltrials.gov/ct2/show/nct03832946
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension (REBUILD)
This is a Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy. The primary objective in this study is to identify the optimal dose and verify the efficacy of iNO in subjects with pulmonary hypertension and pulmonary fibrosis currently receiving treatment with long term oxygen therapy.
For more information:https://clinicaltrials.gov/ct2/show/NCT03267108
Chronic Obstructive Pulmonary Disease Clinical Trial
A Prospective, Multicenter, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support (VENT-AVOID)
The purpose of this research study is to test the safety and efficacy of using a new medical study device called the Hemolung Respiratory Assist System (Hemolung). This study will compare treatment with the Hemolung system to standard medical treatment for people with (Chronic Obstructive Pulmonary Disease (COPD) who have been admitted to a hospital intensive care unit (ICU) because of severe difficulty in breathing. The Hemolung is an investigational medical device that has not yet been approved by the U.S. Food and Drug Administration.
For more information:https://www.clinicaltrials.gov/ct2/show/NCT03255057