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Cardiac Clinical Trials

Centennial Heart is a proven leader in Cardiovascular Research. In 2007, Sarah Cannon Research Institute (SCRI) established our practice as a strategic investigative site for cardiovascular research in Nashville. Now, the program has expanded to 23 sites and is known as the HCA Healthcare Research Institute (HRI) specializing in: interventional cardiology, electrophysiology, cardiovascular disease, surgery and structural heart.

At Centennial Heart, our team pioneers clinical trials to constantly innovate solutions and improve patient outcomes.

We are proud to partner with SCRI in transforming cardiovascular therapies and advancing patient care. SCRI sets the standard for effectively managed, reliable clinical research trials.

National Leaders in Cardiac Research

Our nationally recognized cardiovascular research program is designed to provide state of the art, inventive approaches to clinical trial management. At Centennial Heart, our team pioneers clinical trials to constantly innovate solutions and improve patient outcomes.

Our physicians actively manage multiple studies with HCA Research Institute. Dr. Samuel Horr is the Clinical Director of Cardiovascular Research.

Condition

Coronary Artery Disease with severely calcified lesions

Intervention

PCI with orbital atherectomy versus conventional balloon angioplasty

Location
TriStar Centennial
Sponsor
Cardiovascular Systems, Inc.
Principal Investigator
Brian Jefferson, MD
Research Coordinator
Drew Quillen
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT03108456

Condition

Chronic Total Occlusion

Intervention

PCI of the Chronic Total Occlusion

Location
TriStar Centennial
Sponsor
Minneapolis Heart Institute
Principal Investigator
Brian Jefferson, MD & Taral Patel, MD
Research Coordinator
Drew Quillen
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT02061436

Condition

Symptomatic patients with severe tricuspid regurgitation

Intervention

Compare Abbott TriClip to control/medical therapy

Location
TriStar Centennial
Sponsor
Abbott
Principal Investigator
Samuel Horr, MD
Research Coordinator
Abdullah Shamsuddin
Specialty
Structural

Clinicaltrials.gov

ClinicalTrials.gov Identifier: NCT03904147

Condition

Degenerative mitral regurgitation

Intervention

Compare the Edwards PASCAL System for transcatheter mitral valve repair to the Abbott MitraClip

Location
TriStar Centennial
Sponsor
Edwards
Principal Investigator
John Riddick, MD
Research Coordinator
Abdullah Shamsuddin
Specialty
Structural

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT03706833

Condition

Heart Failure with functional mitral regurgitation

Intervention

Carillon implant versus control

Location
TriStar Centennial
Sponsor
Cardiac Dimensions
Principal Investigator
Andrew Goodman, MD
Research Coordinator
Abdullah Shamsuddin
Specialty
Structural

ClinicalTrials.gov

In start up

Condition

Moderate-to-severe or severe Mitral Regurgitation

Intervention

Tendyne mitral valve system versus MitraClip system

Location
TriStar Centennial
Sponsor
Abbott
Principal Investigator
Sreekumar Subramanian, MD
Research Coordinator
Brenda Merkelz
Specialty
Structural

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT03433274

Condition

Uncontrolled Hypertension

Intervention

Renal denervation versus control

Location
TriStar Centennial
Sponsor
Medtronic
Principal Investigator
Brian Jefferson, MD
Research Coordinator
Molly Harper
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT02439775

Condition

Aortic valve stenosis that is being treated with an approved TAVR device

Intervention

Sentinel Cerebral Protection System versus Control (no sentinel)

Location
TriStar Centennial
Sponsor
Boston Scientific
Principal Investigator
Samuel Horr, MD
Research Coordinator
Brenda Merkelz
Specialty
Structural

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04149535

Condition

Heart failure (HF) patients on maximum Guideline Directed Medical Therapy (GDMT) with elevated BNP labs or at least one HF hospitalization in last year

Intervention

V-wave interatrial shunt versus no V-wave shunt

Location
TriStar Centennial
Sponsor
V-Wave
Principal Investigator
A Thomas McRae III, MD
Research Coordinator
Drew Quillen

Specialty
Heart Failure

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT03499236

Condition

Non-valvular Atrial Fibrillation (Afib)

Intervention

Watchman FLX versus Novel Oral Anticoagulants (NOACs)

Location
TriStar Centennial
Sponsor
Boston Scientific Corporation
Principal Investigator
Samuel Horr, MD
Research Coordinator
Molly Harper
Specialty
Electrophysiology

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04394546

Condition

Aortic Valve replacement with an On-x mechanical valve

Intervention

Eliquis (apixaban) versus standard of care (Coumadin/warfarin)

Location
TriStar Centennial
Sponsor
CryoLife
Principal Investigator
Seenu Reddy, MD
Research Coordinator
Molly Harper
Specialty
Structural

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04142658

Condition

Severe primary mitral regurgitation at moderate surgical risk and whose mitral valve (MV) has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team

Intervention

Mitraclip vs surgery

Location
TriStar Centennial
Sponsor
Abbott
Principal Investigator
Sreekumar Subramanian, MD
Research Coordinator
Brenda Merkelz
Specialty
Structural

ClinicalTrials.gov

ClinicalTrials.gov Identifier: NCT04198870

Condition

Patients with small aortic annulus and symptomatic severe native aortic stenosis

Intervention

EVOLUT versus SAPIEN transcatheter aortic valve replacement devices

Location
TriStar Centennial
Sponsor
Medtronic
Principal Investigator
Andrew Goodman, MD
Research Coordinator
Abdullah Shamsuddin
Specialty
Structural

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04722250

Condition

Adults hospitalized with COVID-19

Intervention

Compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients

Location
TriStar Centennial
Sponsor
University of Pittsburg Medical Center, Matthew Neal, MD
Principal Investigator
Andrew Goodman, MD
Research Coordinator
Brenda Merkelz
Specialty
COVID

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04505774

Condition

ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Intervention

Impella CP placement prior to reperfusion with Primary PCI

Location
TriStar Centennial
Sponsor
Abiomed
Principal Investigator
Andrew Goodman, MD
Research Coordinator
Drew Quillen
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT03947619

Condition

Patients with diabetes hospitalized with acute decompensated Heart Failure (ADHF)

Intervention

Dapagliflozin +  Protocolized Diuretic Therapy versus Control (Protocolized Diuretic Therapy)

Location
TriStar Centennial
Sponsor
Vanderbilt University Medical Center
Principal Investigator
A Thomas McRae III, MD
Research Coordinator
Drew Quillen
Specialty
Heart Failure

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04298229

Condition

Heart attack (Myocardial Infarction)

Intervention

Empagliflozin versus placebo to see if it helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease

Location
TriStar Centennial
Sponsor
Boehringer Ingelheim
Principal Investigator
Ann Gage, MD
Research Coordinators
Drew Quillen and Molly Harper
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04509674

Agent IDE

Condition

Patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery

Intervention

Agent DCB versus PTCA balloon catheter

Location
TriStar Centennial
Sponsor
Boston Scientific Corporation
Principal Investigator
Andrew Goodman, MD
Research Coordinator
Drew Quillen
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04647253

Condition

Coronary Artery Disease, Ischemic Heart Disease

Intervention

Comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation

Location
TriStar Centennial
Sponsor
Philips
Principal Investigator
Brian Jefferson, MD
Research Coordinator
Drew Quillen
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04451044

Enrolling by invitation

Condition

Acute decompensated heart failure

Intervention

Cardionomic cardiac pulmonary nerve stimulation therapy versus standard of care

Location
TriStar Centennial
Sponsor
Cardionomic Inc.
Principal Investigator
Ashley Bock, MD
Research Coordinator
Drew Quillen
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04814134

Condition

High-risk PCI in patients with reduced left-sided heart function

Intervention

Impella CP (or Impella 2.5) device compared to current standard of care

Location
TriStar Centennial
Sponsor
Abiomed Inc.
Principal Investigator
Andrew Goodman, MD
Research Coordinator
Drew Quillen
Specialty
Interventional

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04763200

In start up

Condition

Patients with severe degenerative mitral regurgitation (DMR)

Intervention

Harpoon beating heart mitral valve repair system

Location
TriStar Centennial
Sponsor
Edwards
Principal Investigator
Sreekumar Subramanian, MD
Research Coordinator
Brenda Merkelz
Specialty
Structural

ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT04375332