HUMC's Reputation as a Go-To Hospital for Elite Research   

Hackensack University Medical Center a Leading Destination for Top Clinical Trials

Depth of experience with complex case, high volumes and multidisciplinary collaboration rank attracts elite, multicenter research studies

Hackensack University Medical Center a Leading Destination for Top Clinical Trials

For outstanding clinical outcomes in the most complex cases, advanced surgical and imaging technology, multispecialty teams dedicated to mastering the latest procedures and a robust research team, Hackensack University Medical Center is consistently chosen to participate in landmark clinical trials. Haroon Faraz, M.D., director of Interventional Cardiology Research at Hackensack University Medical Center, says, “We’ve grown the program into an elite institute with involvement in all these cutting edge trials.” The team participates in the following research:

ARISE II – Hackensack University Medical Center is the only center in New Jersey participating in the ARISE II trial of the GORE ascending stent graft device trial. This device allows a minimally invasive approach to address ascending aortic pathologies, rather than a larger open operation. This could enable patients to return home the next day. This trial is a collaborative effort between our outstanding cardiac and vascular surgeons who have extensive experience in treating these types of patients with these types of problems. (P.I. - Yuriy Dudiy, M.D.)

EVOID-AS – Hackensack University Medical Center recently enrolled its first patients in a novel trial testing the oral diabetes medication evogliptin to reduce the progression of mild and moderate aortic stenosis. While the center offers the latest in interventional and surgical techniques for advanced cases of aortic stenosis, this trial, available at a small number of select sites nationwide, seeks to address disease progression. (P.I. - Ankitkumar Patel, M.D.)

Impella ECP – The top-enrolling center in the world, Hackensack University Medical Center is studying the world’s smallest heart pump technology support at 9 French—during high-risk elective or urgent percutaneous coronary intervention procedures. The center was selected due to the experience of high-volume, high-risk interventional cardiologists to evaluate the new pump’s function in high-risk, high-complexity interventions. The center is applying CT-fusion in a hybrid OR/cath lab setting to create a live 3D model to help optimally position the Impella ECP in real-time interventions and is the only location to offer this level of collaboration between interventionists and advanced cardiac imagers. (P.I. - Ankitkumar Patel, M.D.)

PROTECT IV – Hackensack University Medical Center is a leading site for a global trial comparing the benefits of HRPCI versus without Impella support. The results could guide significant protocol shifts in interventional treatment of patients with complex coronary artery disease and left ventricular dysfunction. (P.I. - Haroon Faraz, M.D.)

SAFE-MCS – As a full-spectrum interventional cardiology center doing complex, challenging cases, Hackensack University Medical Center was tapped as one of fifteen centers to participate in a trail to evaluate the safety of the Saranas Early Bleed Monitoring System in complex, high-risk percutaneous coronary interventions using mechanical circulatory support. This sheaf device contains sensors that chirp and light up when internal bleeding is detected, typically before a surgeon would otherwise be aware. Minimizing blood loss and preventing surgical anemia had significant potential to affect patient outcomes in these already complex cases. (P.I. - Ankitkumar Patel, M.D.)

STEMI-DTU – This multicenter trial will compare mechanical LV unloading with the Impella CP device for 30 minutes before primary PCI to primary PCI alone. As a participating center, Hackensack University Medical Center will help determine if this mechanical assist approach reduces infarct size and improves heart failure and mortality rates in ST-elevation myocardial infarction (STEMI) cases. (P.I. - Haroon Faraz, M.D.)

RECOVER IV – Hackensack University Medical Center was invited as one of ten centers nationwide to join a landmark trial to assess whether percutaneous coronary intervention (PCI) with Impella support initiated prior is superior to PCI without Impella support in cardiogenic shock cases. (P.I. - Haroon Faraz, M.D.)

ROADSTER 3 – Hackensack University Medical Center is participating in an FDA post-approval study of TCAR in standard risk patients with significant carotid artery disease to evaluate real-world use of the ENROUTE Transcarotid Stent System in conjunction with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy (CEA). With its large-scale practice and registry, Hackensack University Medical Center is poised to help determine whether TCAR offers as good as or a better standard of care for all patients—not just high-risk or moderate-risk cases—which could open Medicare-approval possibilities for this minimally invasive option across the board. (P.I. - David O’Connor, M.D.)

EVOLVE - This pragmatic, randomized, multicenter trial is being conducted to evaluate the effectiveness of early treatment with evolocumab plus routine lipid management compared with routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]). (P.I. - Pranaychandra J. Vaidya, M.D.)

COSIRA II - This multicenter, randomized (1:1 ratio), double-blinded, sham-controlled clinical trial is being conducted to demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. (P.I. - Haroon Faraz, M.D.)

SUMMIT - Hackensack University Medical Center is participating in a clinical trial to study the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of symptomatic mitral regurgitation when compared to MitraClip. Unlike MitraClip, which is used to repair the mitral valve, Tendyne is a catheter-based platform to replace the mitral valve completely. (P.I. – Ryan Kaple, M.D.)

CORCINCH-HF - The CORCINCH-HF Study is designed to evaluate the effectiveness of the AccuCinch Ventricular Restoration System in patients who have heart failure with reduced ejection fraction, which limits the heart’s ability to efficiently squeeze and pump blood to the rest of the body. The AccuCinch device is implanted using a catheter and helps reduce the size of the left ventricle, improving the heart’s ability to squeeze. (P.I. – Ryan Kaple, M.D.)

TricValve - Patients with symptomatic tricuspid regurgitation may be candidates for the TricValve clinical trial. This is a procedure where a valve is placed in the two large veins leading to the heart (superior, vena cava, and inferior vena cava) using catheters to treat the effects of tricuspid regurgitation. (P.I.- Ryan Kaple, M.D.)

Learn more about innovative heart and vascular care at Hackensack University Medical Center.
USNWR Cardiology 2022

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