Cardiovascular Trials

Dr. Brijeshwar Maini medical director of transcatheter therapies for Tenet Healthcare’s Florida region leads the cardiovascular trials at Delray Medical Center (DMC). Dr. Maini works closely beside other cardiologists at DMC and throughout Palm Beach County to offer the most current and minimally invasive treatments to treat a majority of cardiac conditions including mitral regurgitation (MR), heart failure (HF), atrial fibrillation (a-fib), and tricuspid regurgitation (TR).

Mitral regurgitation (MR)

A debilitating, progressive and life-threatening condition in which the valve between the two left-sided chambers (left ventricle and left atrium) does not close properly, causing a backward flow of blood into the heart. The condition can increase the risk of irregular heartbeats, stroke, and heart failure, which can lead to death.

Heart failure (HF)

The inability of the heart to pump blood sufficiently. HF has two classifications:

HF with reduced left ventricular function (HF-rEF)

Occurs when the lower chamber of the heart (left ventricle) becomes larger and is unable to squeeze or contract hard enough to pump the correct amount of oxygen-rich blood to the rest of the body.

HF with preserved left ventricular function (HF-pEF)

A condition where the left ventricle contracts or squeezes normally however, the ventricle is thicker and stiffer than normal, which does not allow it to relax and properly fill with blood. As a result, less blood is pumped to the rest of the body.

Symptoms of either HF-rEF or HF-pEF include but are not limited to shortness of breath (SOB), fatigue, swelling of abdomen, legs and ankles, weight gain, irregular heartbeats, dizziness, and confusion.

Atrial fibrillation (A-fib)

An irregular and often rapid heart rate. Occurs when the upper chambers of the heart (atria) are beating out of sync with the lower chambers (ventricles). This desynchronization can cause blood to collect within the left atrial appendage (LAA) of the heart, which can potentially form a blood clot. Prevention of clot formation is key. Long-term blood thinners are the standard treatment. Symptoms include but are not limited to SOB, weakness, confusion, chest pain and/or pressure.

Tricuspid regurgitation (TR)

A debilitating, progressive and life-threatening condition in which the valve between the two right-sided chambers (right ventricle and right atrium) does not close properly. Symptoms may go unnoticed and may not present until the regurgitation is severe. Symptoms include swelling of the abdomen, legs and the veins in your neck, abnormal heart rhythms, SOB, and fatigue.

The Research Department at Delray Medical Center is in collaboration with several key medical companies in an effort to provide the community with leading breakthrough technology and minimally invasive procedures to improve clinical outcomes in symptomatic patients.

Studies Open to Enrollment

TRILUMINATE Pivotal

Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal
Principal Investigator
Brijeshwar Maini, MD
Sponsor
Abbott
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SUMMIT

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Principal Investigator
Brijeshwar Maini, MD
Sponsor
Abbott
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RELIEVE‐HF TRIAL

REducing Lung congestIon symptoms using the v-wavE shunt in adVancEHeart Failure
Principal Investigator
Brijeshwar Maini MD
Sponsor
V-Wave, Ltd
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CHAMPION-AF

WATCHMAN FLX versus NOAC for EMbolic ProtectION in the Management of Patients with Non-Valvular Atrial Fibrillation
Principal Investigator
Brijeshwar Maini, MD
Sponsor
Boston Scientific Corporation
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THE ENCIRCLE TRIAL

SAPIEN M3 System TransCatheter MItral Valve ReplaCement via TransseptaL AccEss
Principal Investigator
Brijeshwar Maini, MD
Sponsor
Edwards
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Contact the Research Department @ 561.495.3145 or Inforesearch.delray@tenethealth.com with Questions regarding research opportunities at Delray Medical Center