On the leading edge thanks to clinical trials

CLINICAL TRIALS On the leading edge

To ensure patients in our community have access to the most advanced heart treatments, Baptist Health is active in clinical trials.

Clinical trials at Baptist Heart Specialists

By the numbers

January – December 2021

112

patients enrolled in clinical trials

7research staff

27

open trials

2

trials as a top enroller in the U.S.

Baptist Health strives to provide patients with the latest evidencebased treatments and preventive therapies and to foster medical advancements through clinical trials under the direction of the Baptist Health Research Institute. Clinical Research Director Smitha Gubbi, MBBS, CCRC (left), featured here with Doran Cassidy, certified clinical research coordinator (right).

CLINICAL TRIALS

“We are privileged to work with colleagues around the world in clinical studies that help advance health care for our patients.”

Carlos Sotolongo, MD, FACC Cardiologist, Chief of Cardiology at Baptist Beaches

General Cardiology

Enrolling studies

ADI CPM (2021)

Performance assessment of the ADI Cardio Pulmonary Monitoring System (CPM), an at-home heart failure management device. PrincipaI investigator: Ruple Galani, MD

Novo 4665 & Novo 4773 (2021)

Investigate how well semaglutide, an antidiabetic medication, works in people living with heart failure and obesity. The Novo 4773 study includes patients with diabetes. PrincipaI investigator: Ashwini Davuluri, MD

Alleviate (pre-2021)

The study will utilize the market-released Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download for collection of data from which a heart failure risk status can be derived, enabling clinicians to take action before patients’ conditions worsen. PrincipaI investigator: Russell Stapleton, MD

Florida TS (pre-2021)

Data registry of feasibility and long-term outcomes of past and future Takotsubo syndrome patients. PrincipaI investigator: Andre Macedo Dias, MD

WARRIOR (pre-2021)

Determine whether intensive medication treatment to modify risk factors and vascular function in female patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being hospitalized for cardiac reasons. PrincipaI investigator: Ruple Galani, MD

Open studies in follow up

Vesalius (2021)

Assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction or stroke who are at high risk of a cardiovascular event. PrincipaI investigator: Carlos Sotolongo, MD

NOVO 4388-SELECT (pre-2021)

Two separate studies Determine if semaglutide may reduce the risk of having cardiovascular events in patients with obesity and prior cardiovascular disease. PrincipaI investigators: Ashwini Davuluri, MD (Baptist South) and Carlos Sotolongo, MD (Baptist Beaches)

Perspective (pre-2021)

Evaluation of Valsartan vs. Entresto on cognitive function in patients with chronic heart failure. PrincipaI investigator: Carlos Sotolongo, MD

COORDINATE (pre-2021)

Test the effectiveness of an innovative, clinic-level educational intervention, including cardiology and endocrinology partnerships and guidelinerecommended care pathways, to improve the management of patients with Type-II diabetes mellitus and cardiovascular disease. PrincipaI investigators: Ashwini Davulri, MD and Alan Cleland, MD (endocrinology)

Interventional Cardiology

Enrolling studies

DTU (pre-2021)

Demonstrate the safety and effectiveness of primary left ventricular unloading and a 30-minute delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients with anterior ST-Elevation Myocardial Infarction. PrincipaI investigator: Siddharth Wayangankar, MD

Open studies in follow up

Spyral HTN-OFF MED (pre-2021)

Test the hypothesis that renal denervation decreases blood pressure and is safe in absence of antihypertensive medications. PrincipaI investigator: Bharat Gummadi, MD

CLINICAL TRIALS

Electrophysiology

Enrolling studies

HEAL (2021)

Gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, Tyrx™ envelope, or no envelope. PrincipaI investigator: Aaditya Vora, MD

Medtronic PAN PSR Registry (pre-2021)

Provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. PrincipaI investigator: Venkata Sagi, MD

Aveir DR i2i (2022)

Prospective, multicenter, international, single-arm pivotal investigational study to evaluate the safety and effectiveness of the Aveir atrial LP. PrincipaI investigator: Venkati Sagi, MD

Open studies in follow up

EV_ICD (pre-2021)

Demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator System. PrincipaI investigator: Venkati Sagi, MD

Upcoming studies

AdMIRE (2022)

Assess safety and effectiveness of treatment management of atrial fibrillation with the BWI IRE Ablation System. Principal investigator: Venkati Sagi, MD

EVICD-CA (2022)

Provide continued access to the Extravascular Implantable Cardioveter Defibrillator (EV ICD) System. Principal investigator: Venkati Sagi, MD

“The research we do centers around providing something new to our patients with key goals in mind: the new technology or treatment has to be safer and more effective than an existing technology or treatment, and the patient’s satisfaction, experience and quality of life has to be improved beyond what we currently offer. Every trial or study is valuable for our patients.”

Venkati Sagi, MD Electrophysiologist

Structural Heart

Enrolling studies

Catalyst (pre-2021) Evaluate the effectiveness of the Amulet™ LAA occlude compared to novel oral anticoagulants (NOACs), a new class of anticoagulant drug. PrincipaI investigator: Ruby Satpathy, MD

PFO-PAS (pre-2021) Evaluate the safety and effectiveness of the AMPLATZER PFO Occluder in patients with a confirmed patent foramen ovale (PFO). PrincipaI investigator: Ruby Satpathy, MD

Open studies in follow up

Amulet (pre-2021) The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. PrincipaI investigator: Ruby Satpathy, MD

Baptist Health is the first health system in the southeast United States to use the Amplatzer™ Amulet™ Left Atrial Appendage Occluder post-FDA approval. WATCH-TAVR (pre-2021) Evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation undergoing transcatheter aortic valve replacement (TAVR). PrincipaI investigator: Ruby Satpathy, MD

Upcoming studies

Complete TAVR (2022) Compare effectiveness of staged complete revascularization with percutaneous coronary intervention to treat coronary artery disease versus medical management alone in patients with symptomatic aortic valve stenosis undergoing elective transfemoral transcatheter aortic valve replacement. Principal investigator: Siddarth Wayangankar, MD

The Progress Trial (2022) Assess the management of moderate aortic stenosis by clinical surveillance or transcatheter aortic valve replacement. Principal investigator: Ruby Satpathy, MD

Apollo Trial (2022)* Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR System in patients with moderateto-severe or severe symptomatic mitral regurgitation who are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention. *Anticipated clinical trial. Principal investigators: Ruby Satpathy, MD and independent physician Nathan Bates, MD