Clinical Research Trials

At Bryan Heart, our reputation in heart care gives you access to national research trials

Bryan Heart is a well-known and respected partner in national clinical trials. This reputation benefits you by providing access to additional treatment options not otherwise available in our region.

Your treatment team will share information with you if clinical trial participation is an appropriate option to consider for your treatment.

What is a Clinical Research Study?

A clinical research study, also called a clinical trial, is a carefully designed and closely regulated study of the safety and effectiveness of new, innovative procedures, medications or devices. The purpose of any study is to determine if a new therapy will be effective and safe in preventing, diagnosing or treating people with specific diseases or conditions.

How is Clinical Research Conducted?

Clinical research can be a long and detailed process, beginning in the laboratory where proven theories are tested. If successful, the next step is the preclinical phase.

Preclinical Research

This is done before clinical trials (testing in humans) can begin. The main goal of preclinical research is to determine if a product is safe. This applies to drugs, devices and gene therapy. Each type of product may undergo different types of testing. The information collected from these studies is vital so that safe human testing can begin. Drug testing may involve animal testing in two species.

Clinical Research Phases

Clinical research is made up of four phases:

  • Phase I research studies are the first step in testing any new treatment in humans. These studies usually have 20 participants or less and are designed to show whether a treatment is safe in humans. Often this includes healthy volunteers, and in drug studies can include increases in dose to evaluate the best dose.
  • Phase II trials are further tests of safety in a larger number of people, usually 50-200. In addition to safety, effectiveness is beginning to be evaluated, and in drug trials, final dosing regimens are often determined at this phase.
  • Phase III trials are done to prove the effectiveness of the new treatment. Most of these studies compare the new treatment to current standard therapy. In drug studies, this is done by comparing the new study drug to a placebo. A placebo is a harmless, inactive substance. One group of patients will receive the active study drug and one group will receive placebo, so that it can be determined whether the study drug is worse, equal or better than current standard therapy. To prevent any bias on the part of the patient or researchers, the study is ‘blinded’. This means that the patient, the research staff and the doctor do not know which group a patient is in. When the study is complete, data is analyzed and submitted to the FDA for approval of the new treatment.
  • Phase IV trials are done to determine whether a drug already approved by the FDA could be used for new treatments. For example, a drug that was was approved for prevention of clots in orthopedic patients, then being studied in patients with heart disease who need clot prevention.

Learn More About Clinical Research Trials at Bryan Heart

For information on current clinical trials available at Bryan Heart, please call 402-483-3333.

Available Clinical Trials

ADVANCE LAA Occluder Post Approval Study

  • Study Name: A Real-World Study to Observe Outcomes of Patients Undergoing Closure with the Amplatzer™ Amulet™ Left Atrial Appendage Occluder
  • Study Sponsor: Abbott
  • Principal Investigator: Robert Percell, MD
  • Category:
  • Description: This study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device. The Amulet device is intended to reduce the risk of thrombus embolization (blood clot detachment) from the left atrial appendage in patients who have atrial fibrillation and who are at increased risk for stroke and systemic embolism based on risk scores. This objective of this study is to characterize real-world procedural and safety outcomes of the Amulet device.
  • Status: Currently enrolling

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AIM HIGHer

  • Study Name: Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction
  • Study Sponsor: Impulse Dynamics, Inc.
  • Principal Investigator: Robert Percell, MD
  • Category: Heart Failure
  • Description: Evaluate the efficacy and safety of cardiac contractility modulation (CCM®) therapy, utilizing the OPTIMIZER® Smart Mini System in patients with symptomatic heart failure with preserved ejection fractions (HF with EF 40-60%). This system is indicated for the improvement of health status, functional capacity, heart failure related adverse events, and cardiovascular mortality.
  • Status: Currently enrolling

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COMPLETE TAVR

  • Study Name: A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization with Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients with Symptomatic Aortic Valve Stenosis undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement
  • Study Sponsor: Centre of Cardiovascular Innovation
  • Principal Investigator: Matthew Johnson, MD
  • Category: Coronary Artery Disease
  • Description: This study is being conducted in aortic valve stenosis patients who have undergone successful TAVR with a balloon expandable heart valve who also have coronary artery disease (CAD) or narrowing of the heart arteries. The study will compare opening blockages in the coronary arteries with a stent OR treating the blockages with medication only.
  • Status: Currently enrolling

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DAPA ACT HF-TIMI 68

  • Study Name: Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure
  • Study Sponsor: TIMI Study Group/Brigham and Women’s Hospital
  • Principal Investigator: Clyde Meckel, MD
  • Category: Heart Failure
  • Description: A clinical trial to determine if dapagliflozin, a medication currently approved to improve blood sugar control in Type 2 diabetes, and to reduce the risk of hospitalizations for heart failure in patients with Type 2 diabetes with heart disease, or are at risk for heart disease, can also treat patients with heart failure that have not been diagnosed with heart disease. This trial will evaluate if it is safe and beneficial to start dapagliflozin during a current admission for heart failure.
  • Status: Currently enrolling

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LIBREXIA ACS

Study Name: A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
Study Sponsor: Janssen Research and Development
Principal Investigator: Clyde Meckel, MD
Category: Coronary Artery Disease

Description: The purpose of this study is to see if an experimental drug, called Milvexian, is safe and useful in reducing risk of developing blood clots, stroke or another heart attack among patients with a recent heart attack or angina episode, compared to placebo (inactive medication) in addition to standard medication. Patients will be enrolled within 7 days of their heart attack.

Status: Currently enrolling

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OCEAN(a) - Outcomes

OCEAN(a)-Outcomes

  • Study Name: Olpasiran Trials of Cardiovascular Events Lipoprotein(a) reduction – Outcomes trial
  • Study Sponsor: Amgen, Inc.
  • Principal Investigator: Chad Travers, MD
  • Category: Cardiovascular Disease
  • Description: This study will compare the impact of olpasiran on cardiovascular events in participants with cardiovascular disease and elevated lipoprotein (a) (Lp[a]). Primary objective is to compare olpasiran to placebo (inactive medication) on the risk of coronary heart disease death, heart attack or urgent coronary revascularization. Anticipated reduction of Lp(a) are expected to result in a significant cardiovascular benefit in patients with cardiovascular disease.
  • Status: Currently enrolling
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ORION-4

Study Name: A trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease (HPS-4/TIMI 65/ORION-4)
Study Sponsor: The University of Oxford and Novartis
Principal Investigator: Clyde Meckel, MD
Category: Cardiovascular Disease

Description: This study will investigate the safety and effectiveness of a new cholesterol-lowering medication, inclisiran, in lowering the risk of heart attacks and strokes in patients who have already been diagnosed with these conditions, or who have had a procedure to treat a blocked artery (heart, neck, or leg). Screening will be done to determine eligibility.

Status: Closed to enrollment 

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SPIRIT XLV Post Approval Study

  • Study Name: The Xience Skypoint Large Vessel Post-Approval Study
  • Study Sponsor: Abbott
  • Principal Investigator: Natraj Katta, MD
  • Category: Coronary Artery Disease
  • Description: This is an observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel stent (diameters 4.5 mm and 5.0 mm) coronary stent systems.
  • Status: Currently enrolling
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TARGET-IV NA

Study Name: Multicenter randomized assessment of the Firehawk™ rapamycin TARGET eluting cobalt chromium coronary stent system- North America trial
Study Sponsor: Shanghai MicroPort Medical (Group) Co, Ltd.
Principal Investigator: Natraj Katta, MD
Category: Coronary Artery Disease

Description: A study to compare the efficacy (how well it works) and safety of a new drug-coated stent called the Firehawk™ to other similar drug-coated stents that are already approved by the FDA. The Firehawk™ stent is currently investigational and not approved by the Food and Drug Administration (FDA). A stent is a medical device that is inserted into an artery in the heart to open a blockage(s). A drug-eluting stent (DES) is a special stent that releases a drug that helps prevent blockages from coming back, often called restenosis.

Status: Closed to enrollment 

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VICTORIAN-INCEPTION

Study Name: Management of LDL-cholesterol with inclisiran + usual care compared to usual care alone in participants with a recent acute coronary syndrome
Study Sponsor: Novartis
Principal Investigator: Clyde Meckel, MD
Category: Coronary Artery Disease

Description: The purpose of the study is to evaluate the safety and effectiveness of inclisiran, which effectively lowers LDL cholesterol or bad cholesterol in participants who recently had an acute coronary syndrome (e.g. heart attack). Inclisiran has been approved by the Food and Drug Administration (FDA) to treat people with elevated LDL cholesterol. Participants will be selected to either receive standard therapy with a cholesterol lowering medication (statin) or a statin plus inclisiran.

Status: Currently enrolling

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