Cardiology Clinical Trials Enrolling in 2018

Intracoronary imaging continues to be the core of interventional research led by Richard Shlofmitz, M.D., Chairman of Cardiology. The objective is to understand the impact of imaging-guided PCI (OCT-optical coherence imaging and IVUS) on PCI procedural and clinical outcomes. Dr. Shlofmitz is also leading an investigation of complex calcified lesion preparation using orbital atherectomy prior to stenting, combined with intravascular imaging (OCT) for the evaluation of procedural success and clinical outcomes.

Allen Jeremias, M.D., a leading expert in FFR (fractional flow reserve), is conducting multiple studies investigating FFR and iFR in their predictive value of future cardiovascular events. In addition, he is also assessing the value of derived FFR using computational flow dynamics based on angiographic images.

Expanding clinical trials designed to evaluate novel treatments of mitral regurgitation are underway at St. Francis Hospital. These trials are aimed at either replacement or repair of the mitral valve. The structural heart disease team led by George Petrossian, M.D., and Newell Robinson, M.D., is investigating mitral valve replacement via a catheter-based procedure, possibly avoiding the need for open heart surgery. In addition to the mitral valve, the team is also actively engaged in the research of transcatheter aortic valve replacement (TAVR).

In the area of heart failure, Rita Jermyn, M.D., Director of the Center for Advanced Therapeutics, is involved in multicenter drug and device trials aimed at the optimization of treatment of heart failure, reduction in heart failure hospitalization, and reduction in cardiovascular mortality. Dr. Jermyn is also a renowned expert in CardioMEMS, a system for wirelessly measuring and monitoring pulmonary artery pressure and heart rate. Her research is focused on improving the quality of life for heart failure patients.

The Cardiac Imaging Department, led by Jane Cao, M.D., has a large number of original research protocols encompassing echocardiography, nuclear imaging, cardiac CT, and MRI technologies. The accessibility of multi-modality imaging creates a unique opportunity to investigate the relationship of myocardial tissue property and myocardial mechanical performance, led by Dr. Cao and Lin Wang, M.D. A broad interest in qualitative and quantitative myocardial perfusion research has led to investigations using MRI, CT, echocardiography, and PET imaging led by Madhavi Kadiyala, M.D., Timothy Christian, M.D., Aasha Gopal, M.D., Andrew Van Tosh, M.D., and Eddy Barasch, M.D., continues to evaluate physiologic insights and clinical outcomes associated with aortic stenosis. Artificial intelligence is an important area of leading edge research in cardiac imaging. Led by senior scientist James Goldfarb, Ph.D., there is exciting development of artificial intelligence in large scale cardiac imaging analysis.

Another senior scientist Yulee Li, Ph.D. and his team are working on an NIH funded study to develop techniques to increase the speed of cardiac imaging. Dr. Cao is collaborating with engineers to develop 3D printing to investigate the role of personalized planning in complex cardiac device deployment.

Please call (516) 562-6790 for more information about any of these trials.  

Nationwide trial targets better treatment for persistent atrial fibrillation

St. Francis is participating in a large clinical trial focused on whether a combined treatment for atrial fibrillation may be more effective than pulmonary vein isolation (PVI) alone. “We are very excited about participating in this study,” said Joseph Levine, M.D., Director of Electrophysiology at St. Francis and principal investigator. “It may offer new hope for patients who’ve undergone repeated ablations, but whose atrial fibrillation persists.”

Called the aMAZE Trial, the study will compare if PVI and closure of the left atrial appendage using the LARIAT procedure may treat atrial fibrillation better than PVI only. The LARIAT procedure involves placement of a suture over the left atrial appendage.

“It’s a way of isolating the left atrial appendage so that any electrical stimulation arising in the appendage is no longer able to foster afib,” said George Petrossian, M.D., Director of Interventional Cardiovascular Procedures and co-investigator. The LARIAT is approved by the U.S. Food and Drug Administration for use general surgery to close soft tissue, but it has not been studied extensively to close the left atrial appendage in afib patients who are receiving catheter ablation, according to the trial website.

A total of 650 patients from 65 sites are expected to participate in the trial, including patients from St. Francis. Patients will be randomized to have PVI alone or the LARIAT procedure followed by PVI about a month later. Although results from the trial are not expected for at least a year, Dr. Petrossian is hopeful that the outcomes will offer some promise to patients with persistent afib. “There could potentially be combined procedures to improve efficacy and help patients who are symptomatic to have less palpitations,” he said.

The full name of the trial is aMAZE Trial: Left Atrial Appendage Ligation with the LARIAT Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation (PVI) for Persistent or Longstanding Persistent Atrial Fibrillation.


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