Delray Medical Center’s Clinical Research Trials Offer Patients Innovative Treatment Options

With the goal of improving patient outcomes and quality of life, Delray Medical Center performs neuroscience, cardiovascular, trauma, physical therapy and nursing clinical trials. The studies evaluate therapies, drugs, diagnostic tools and practices to enhance patient care.

The following trials are currently being conducted or have recently been completed at Delray Medical Center:

Neuroscience Trials

Neuroscience and stroke trials are overseen by Dr. Nils Mueller-Kronast, regional medical director of neurosciences for Tenet’s Florida region. One of his major goals is to assess the outcomes associated with the use of devices and medications intended to restore blood flow in patients experiencing acute ischemic strokes. Time is brain, and every minute in which a large vessel ischemic stroke is untreated, the patient loses 1.9 million neurons. Reducing this timeline is a major focus of the comprehensive stroke center at Delray Medical Center. 

Dr. Lloyd Zucker, chief of neurosurgery at Delray Medical Center, leads the neuro-oncology research trials, which include the use of fluorescence-guided surgery for brain tumors. The technology illuminates cancer cells to help identify and remove smaller tumors that could otherwise go undetected. Other neuro-oncology research trials currently underway at Delray Medical Center include minimally invasive brain surgery and interstitial laser thermal therapy.

surgical procedure for brain cancer
Caption: Fluorescence-guided surgical procedure for brain cancer patients.

Cardiovascular Trials

The cardiovascular trials at Delray Medical Center are led by Dr. Brijeshwar Maini, medical director of transcatheter therapies for Tenet Healthcare’s Florida region, and Dr. Brian Bethea, regional medical director of cardiovascular surgery for Tenet’s Florida region.

Transcatheter Aortic Valve Replacement (TAVR) procedures were traditionally reserved for high-risk patients, but research is opening doors for other patients, including those who are low-risk, to benefit from this treatment option. TAVR is especially beneficial for individuals who are not suitable candidates for traditional open-heart surgery. The hospital started performing the advanced minimally invasive procedure for patients with severe aortic stenosis (AS) in January of last year. AS occurs when the aortic valve does not open as it should, making the heart work harder to pump blood through the body. Left untreated, severe AS can lead to heart failure or even sudden death.

To treat AS, Dr. Bethea and Dr. Maini lead a study using Medtronic’s CoreValve® Evolut® R Aortic Valve Replacement, which is implanted using an artery that leads to the heart and is designed to work like a patient’s own heart valve. One benefit of the CoreValve Evolut R implant is that it can immediately make the heart valve work again and reduce pain.

In addition, through the Tendyne Transcatheter Mitral Valve Replacement (TMVR) research trial, Dr. Bethea and Dr. Maini can offer therapy for mitral regurgitation (MR) to a broader patient population. MR is a debilitating, progressive and life-threatening disease in which a leaky mitral valve causes a backward flow of blood into the heart. The condition can raise the risk of irregular heartbeats, stroke and heart failure, which can be deadly. The TMVR device may be a solution for patients with MR who are not surgical candidates for traditional open procedures to receive therapy.

Nursing Research and Evidence-Based Projects (IRB exempt)


Study Name

Implementation of palliative care consult form in critical care unit (CCU): effects on length of stay
Principal Inves​tigator
Jennifer Fiorato, RN, BSN – CCU
Sponsor
Nursing initiated at Delray Medical Center

Study Name
Use of scripting to improve patient perception of nursing helping with pain in post-op adults patients in rehab hospital
Principal Inves​tigator
Gail Rubin, RN, MSN PRH
Sponsor
Nursing initiated at Delray Medical Center

Study Name
Effects of pharmacist-led medication discharge rounding in TISD
Principal Inves​tigator
Sari Viitaniemi, RN, MSN, CCRN TCRN, Trauma ICU
Sponsor
Nursing initiated at Delray Medical Center

Study Name
CAM-ICU delirium assessment: overcoming the barriers in adult trauma critical care unit*
Principal Inves​tigator
Sari Viitaniemi, RN, MSN, CCRN TCRN, Trauma ICU
Sponsor
Nursing initiated at Delray Medical Center

Study Name
Effects of implementing skin bundle in addition to standard skin protocols in Trauma ICU and Trauma Stepdown**
Principal Inves​tigator
Marilou Salvant, RN, BSN, CCRN, TICU/TISD
Sponsor
Nursing initiated at Delray Medical Center

Study Name
Preventing device-related pressure ulcers**
Principal Inves​tigator
Ronela Arandela, RN, MSN, CCRN, CSU
Sponsor
Nursing initiated at Delray Medical Center

Study Name
Will a standardized transition plan of care decrease heart failure admission rates on a cardiac telemetry unit?
Principal Inves​tigator
Gabrielle Cassman, RN, MSN, Cardiac Telemetry
Sponsor
Nursing initiated at Delray Medical Center

Study Name
Assessing differences in perceived needs in families and nurses**
Principal Inves​tigator
Sari Viitaniemi, RN, MSN, CCRN TCRN, Trauma ICU
Sponsor
Nursing initiated at Delray Medical Center

**project completed

Trauma Research


Study Name

Assessing the efficacy of IV ibuprofen for the treatment of pain in orthopedic trauma patients
Principal Inves​tigator
Russell Weisz, MD
Sponsor
Delray Medical Center

Study Name
A comprehensive retrospective assessment of factors including outcomes following trauma
Principal Inves​tigator
Marcos Bukur, MD
Sponsor
Investigator initiated

Neurosciences Research


Study Name

*STRATIS:  Systematic evaluation of patients treated with neurothrombectomy devices for acute ischemic stroke
Principal Inves​tigator
Nils Mueller-Kronast, MD, Ali Malek, MD, Ritash Kaushal, MD
Sponsor
Covidien LP
* Closed to Enrollment

Study Name
Safety and efficacy of image-guided tran-sulcul tubular corridors for hematoma evacuation
Principal Inves​tigator
Llyod Zucker, MD
Sponsor
Investigator initiated

Study Name
*Safety and efficacy of the Six Pillar Approach in tumor patients (retrospective registry)
Principal Inves​tigator
Lloyd Zucker,MD
Sponsor
Investigator initiated
* Closed to Enrollment

Study Name
Patient-centered research into outcomes stroke patients prefer and effectiveness
Principal Inves​tigator
Nils Mueller-Kronast, MD
Sponsor
DCRI-Duke Clinical Research Institute

Study Name
Dabigatran Etexilate for secondary stroke prevention in patients with embolic stroke of underdetermined source (Respect-Esus)
Principal Inves​tigator
Nils Mueller-Kronast, MD
Sponsor
Boehringer Ingelheim Pharmaceuticals, Inc.

Study Name
Immunotherapy in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy (ICT-107)
Principal Inves​tigator
Llyod Zucker, MD
Sponsor
ImmunoCellular Therapeutics, Ltd.

Study Name
A multicenter study of five- amunolevulinic acid to enhance visualization of malignancy in patients with newly diagnosed or recurrent  malignant gliomas
Principal Inves​tigator
Llyod Zucker, MD
Sponsor
Dr. Costas Hajipanayis/Mount Sinai Beth-Israel, NX Development Corporation

Study Name
Trevo Retriever Registery
Principal Inves​tigator
Nils Mueller-Kronast, MD, Ali Malek, MD
Sponsor
Stryker Neurovascular

Cardiovascular Research


Study Name

Tendyne CoreValve® Evolut® R Aortic Valve Replacement to treat severe aortic stenosis
Principal Inves​tigator
Brij Maini, MD, Brian Bethea, MD
Sponsor
Medtronic, Inc.

Study Name
Amulet left atrial appendage occulder
Principal Inves​tigator
Brij Maini, MD
Sponsor
St. Jude Medical

Study Name
*System Post Approval Study (S-ICD PAS)
Principal Inves​tigator
E. Martin Kloosterman, MD,
Sponsor
Cameron Health, Inc., a subsidiary of Boston Scientific Corporation
*Closed to Enrollment

Study Name
The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Registry
Principal Inves​tigator
Brian Bethea, MD
Sponsor
National Health & Lung Blood Institute (NHLBI)

Study Name
Safety and efficacy study of the Medtronic CoreValve System in the treatment of severe symptomatic aortic stenosis in intermediate risk subjects who need aortic valve replacement (intermediate risk)
Principal Inves​tigator
Brij Maini, MD, Brian Bethea, MD
Sponsor
Medtronic, Inc.

Study Name
Coronary interventions in high-risk patients using a novel percutaneous left ventricular support device HeartMate PHP System (Shield 2)
Principal Inves​tigator
PI: Brij Maini, MD,  Sub I: Phillip Habib, MD & Brian Bethea, MD
Sponsor
​St. Jude Medical/Abbott

Study Name
Reprise 3 Continuing Access: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through implementation of Lotus Valve System - Randomized Clinical Evaluation
Principal Inves​tigator
Brij Maini, MD, Brian Bethea, MD
Sponsor
Boston Scientific Corporation

Study Name
Parachute 4: Percutaneous ventricular restoration in chronic heart failure due to ischemic heart disease
Principal Inves​tigator
Brij Maini, MD, Brian Bethea, MD
Sponsor
CardioKinetix, Inc.

Study Name
The TAVR-MitraClip Study, version one: evaluation of outcomes in patients with transcatheter aortic valve replacement (TAVR) and MitraClip (Registry)
Principal Inves​tigator
Brij Maini, MD
Sponsor
Cedars-Sinai

Study Name
Transcatheter aortic valve replacement (TAVR) in patients with the Medtronic TAVR in patients at low risk for surgical aortic valve replacement (SAVR) (Evolut-R low risk)
Principal Inves​tigator
Brij Maini, MD, Brian Bethea, MD
Sponsor
Metronic, Inc.

Study Name
*The lipid rich plaque study (LRD)
Principal Inves​tigator
Robert Carida, MD
Sponsor
InfraReDex, Inc.

Study Name
*Evaluation of ACUITY x4 Quadripolar Coronary Venous Leads and RELIANCE 4-Front Defibrillation Leads (NAVIGATE)
Principal Inves​tigator
PI: E. Martin Kloosterman, MD   Sub-I: Murray Rosenbaum, MD, Jonathan Rosman, MD
Sponsor
Boston Scientific, CRM (?)
*Closed to Enrollment

Study Name
*Repositionable percutaneous replacement of stenotic aortic valve through implantation of Lotus Valve System (randomized clinical evaluation) Reprise 3
Principal Inves​tigator
PI: Brian Bethea, MD   Sub-I: Brij Maini, MD
Sponsor
Boston Scientific Corporation
*Closed to Enrollment

Study Name
*Capture information via automatic threshold evaluation
Principal Inves​tigator
Faren Angella
Sponsor
Boston Scientific Corporation
*Close to Enrollment