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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.


Study Name
A Randomized Evaluation of the TriGuard HDH Embolic Deflection Device to Reduce the Impact of Cerebral Embolic Lesions after Trans Catheter Aortic Valve Implantation (REFLECT)
Principal Investigator
Brij Maini, MD & Brian Bethea, MD
Sponsor
Keystone Heart, Ltd.

Study Name
Expanded Clinical study of Tendyne Mitral Valve System
Principal Investigator
Brij Maini, MD & Brian Bethea, MD
Sponsor
Tendyne Holdings, Inc.

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

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

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) (SURTAVI)
Principal Investigator
Brij Maini, MD, Brian Bethea, MD
Sponsor
Medtronic, Inc.
*Closed Enrollment

Study Name
Coronary interventions in high-risk patients using a novel percutaneous left ventricular support device HeartMate PHP System (Shield 2)
Principal Investigator
Brij Maini, 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
Principal Investigator
Brij Maini, MD, Brian Bethea, MD
Sponsor
Boston Scientific Corporation

 

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 Investigator
Brij Maini, MD, Brian Bethea, MD
Sponsor
Metronic, Inc.

Study Name
Evaluation of ACUITY x4 Quadripolar Coronary Venous Leads and RELIANCE 4-Front Defibrillation Leads (NAVIGATE)
Principal Investigator
E. Martin Kloosterman
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 Investigator
Brian Bethea, MD, Brij Maini, MD
Sponsor
Boston Scientific Corporation
*Closed to Enrollment

Study Name
Portico™ Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO)
Principal Investigator
Brij Maini, MD and Brian Bethea, MD
Sponsor
St. Jude Medical


Study Name
SCOUT Study: Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
Principal Investigator
Brij Maini, MD and Brian Bethea, MD
Sponsor
Mitralign, Inc.

Study Name
REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
Principal Investigator
Eric Lieberman, MD
Sponsor
Corvia Medical, Inc.

Study Name
Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)
Principal Investigator
Brij Maini, MD and Brian Bethea, MD
Sponsor
Caisson Interventional, LLC

Research & Clinical Trials