Clinical Trials
Participation and leadership in clinical research is instrumental in remaining on the leading edge of technology and new medical therapies. Cardiology Associates, through its physicians and clinical staff, participates in nationally sponsored clinical research in both the areas of interventional devices and drug studies contributing to the growing understanding of the heart and vascular system and to helping to advance the development of effective cardiovascular treatment.
As cardiovascular disease continues to be the number one cause of death and disability in the United States, it is important to remain on the cutting edge of technology and medical therapies. Cardiology Associates has participated in over 35 clinical trials and research studies covering many cardiovascular related areas including interventional devices, cardiovascular testing modalities, congestive heart failure, medical therapies, and preventive treatments. It is our hope to provide results which will make a contribution to our patients here at home as well as to global cardiovascular research.
Participation in clinical research is strictly voluntary and there are strict criteria and guidelines that must be met prior to enrollment in a study. If you are interested in learning more about or participating in a study please contact your physician or one of our clinical research coordinators.
Cardiology Associates is actively involved in the following.
Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)
This is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real-world patient population with hypertension GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5,000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.
Sponsor: Medtronic Vascular
Principal Investigators: Stan Thornton, MD, FACC, FSCAI
Coordinator: Mary Austin RN, CCRC | Cardiology Associates & Rhonda Dickinson RN, CMSRN, CCRP | Infirmary Health
ADVENT PAS
To evaluate the long-term safety and effectiveness profile of the FARAPULSE™ Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).
Sponsor: Boston Scientific
Principal Investigators: E. Matthew Quin, MD, FACC
Sub-Investigators : Robert P. Robichaux Jr. MD, MPH, FACC and Jordan M. Chaisson MD, FACC, FHRS
Coordinator: Mary Austin RN, CCRC
EXPAND G4:
This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip® G4 System.
Sponsor: Abbott
Principal Investigators: M. Wail Hashimi, MD, FACC and John M. Galla, MD, FACC, FSCAI
Coordinator: Lynn Ward, RN, CRC
LIBREXIA:
A phase 3 randomized double blinded placebo controlled, event driven study to demonstrate the efficiency and safety of Milvexian, an Oral Factor XIa Inhibitor after a recent acute coronary syndrome
Sponsor:
Principal Investigators: John M. Galla, MD, FACC, FSCAI
Sub-Investigator: Ruth Wagner, CRNP
Coordinator: Lynn Ward, RN, CRC
PARAMOUNT
PARAMOUNT is a prospective randomized open label trial testing the hypothesis that a personalized management strategy in symptomatic patients with suspicion of coronary artery disease (CAD), using CT-based coronary atherosclerotic plaque assessment by AI-enabled quantitative software improves certainty for diagnosis of CAD, control of CAD risk factors and efficiency of ICA referral with appropriate PCI compared to the usual care strategy based on current AHA/ACC guidelines for care of symptomatic patients with suspicion of CAD.
Sponsor: Cleerly, Inc.
Principal Investigator: Jason Cole MD, FACC
Coordinator: Lynn Ward, RN, BSN, CRC
AltaValve PIVOTAL
AltaValve PIVOTAL Trial is a clinical trial to evaluate the safety and effectiveness of the AltaValve System n treatment of moderate to severe and severe mitral regurgitation (MR) in a targeted patient population. Data gathered in this trial will be used to su[[ort a Pre-Market Application (PMA) submission to the FDA of the AltaValve System, using an appropriately powered sample size to enable assessment of the safety and effectiveness of the AltaValve System to treat MR in the targeted patient population.
Sponsor: 4C Medical Technologies, Inc.
Principal Investigator: M. Wail Hashimi, MD, FACC and R. Lewis Wilson, Jr., FACS
Coordinator: Lynn Ward, RN, BSN, CRC
QDOT-FAST
(Clinical Study for Safety and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH SF-5D System Used With Fast Ablation Mode in Treatment of Patients With Paroxysmal Atrial Fibrillation) is a prospective, multicenter, single-arm study enrolling patients with symptomatic paroxysmal atrial fibrillation indicated for catheter-based pulmonary vein isolation. Primary endpoints were short-term effectiveness (confirmation of entrance block in all targeted pulmonary veins after adenosine/isoproterenol challenge) and short-term safety (primary adverse events). Participants were screened for silent cerebral lesions by magnetic resonance imaging. Patients were followed for 3 months post-ablation.
Sponsor: Heart Rhythm Clinical and Research Solution, LLS (HRCRS)
Principal Investigator: E. Matthew Quin, MD, FACC
Coordinator: Lynn Ward, RN, BSN, CRC
REALAF: Real Time Atrial Fibrillation
An observational, prospective, multi-center, non- randomized trial designed to obtain real-world clinical experience of paroxysmal and persistent atrial fibrillation ablation using RF (radio frequency) catheter and PFA (pulse field ablation) catheter technologies. To asses clinical outcomes, including procedural efficiency, safety, long-term, effectiveness of ablations in the treatment of patients with paroxysmal or persistent atrial fibrillation.
Sponsor: Heart Rhythm Clinical and Research Solutions, LLS (HRCRS)
Principal Investigator: E. Matthew Quin, MD, FACC
Sub-Investigator: Ruth Wagner, CRNP
Coordinator: Lynn Ward, RN, CRC
REPAIR MR:
A randomized controlled trial to compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary Mitral Regurgitation who are at moderate risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by a cardiac surgeon.
Sponsor:
Principal Investigators: M. Wail Hashimi, MD, FACC and R. Lewis Wilson, Jr., FACS
Sub-Investigator: Ruth Wagner, CRNP
Coordinator: Lynn Ward, RN, CRC
Cardiology Associates INTegrally participated in the following.
ARTEMIS
The purpose of this study is to determine how long STEMI and NSTEMI take antiplatelet medication and hospital discharge, and how this influences patients long-term health and use of healthcare resources.
Sponsor: AstraZeneca
Principal Investigator: Jason H. Cole, MD, MSc, FACC
Sub Investigators: M. Wail Hashimi, MD, FACC and Robin Bates, PA-C
Coordinator: Ruth Wagner, RN, CRC
AVEIR:
Clinical investigation intended to evaluate the safety and effectiveness of the Aveir Dual Chamber Leadless Pacemaker system in patients indicated for DDD® pacing indications and the Aveir Atrial Leadless Pacemaker for AAI® pacing indications. This clinical investigation will be conducted under and Investigational Device Exemption (IDE) and is intended to support market approval worldwide.
Sponsor: Abbott
Principal Investigators: D. Scott Kirby, MD, FACC and Chance M. Witt, MD, FACC
Coordinator: Lynn Ward, RN, CRC
Commander / RIVAROX HFA 3001
A randomized, double-blind, event-driven multicenter study comparing the efficacy and safety of oral Rivaroxaban with a placebo for reducing the risk of death, myocardial infarction or stroke in subjects with chronic heart failure and significant coronary artery disease following a hospitalization for exacerbation of heart failure.
Sponsor: Janssen
Principal Investigator: Kenneth M. Burnham, MD, FACC
Sub Investigators: Jason H. Cole, MD, MSc, FACC & Stephanie Cleveland, PA
Coordinator: Ruth Wagner, RN, CRC
Copper A Trial
The purpose of the COPPER –A trial is to asses the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention and restenosis in infrainguinal de novo, restonotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.
Sponsor: Horizons International Peripheral Group, LLC
Principal Investigator: Frank T. Bunch MD, FACC, FSCAI
Coordinator: Mary Austin, RN, CCRC
Copper Trial-B Trial
The purpose of COPPER-B trial is to assess the feasibility, safety, and initial efficacy of paclitaxel administration using the OPC for the prevention of restenosis in infrapopliteal de novo and restenotic lesions and occlusions using a novel catheter, teh OPC.
Sponsor: Horizons International Peripheral Group, LLC
Principal Investigator: Frank T. Bunch, MD, FACC, FSCAI
Coordinator: Mary Austin, RN, CCRC
CREDENCE
Study seeking to determine the accuracy of using anatomic and physiological information measurable by computed tomography features of stenosis, plaque, fractional flow reserve-CT and to compare this measure to stress testing for the detection of myocardial ischemia against the gold standard of cardiac catheterization with fractional flow reserve. The hypothesis of this proposal is that integrating anatomic plaque features with physiologic fraction flow reserve-CT will optimize identification of coronary lesions that are ischemia-causing by computed tomography.
Sponsor: NIH
Principal Investigator: Jason H. Cole, MD, MSc, FACC
Sub Investigators: M. Wail Hashimi, MD, FACC
Coordinator: Ruth Wagner, RN, CRC
EVOLVE
A prospective, multicenter, single-arm study designed to assess the safety of 3 month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System.
Sponsor: Boston Scientific
Principal Investigator: Erik A. Eways, MD, FACC
Coordinator: Ruth Wagner, RN, CRC, CRNP
EXCITE Trial
The EXCITE ISR trial is a prospective randomized controlled trial evaluating the safety and efficacy of Excimer Laser Atherectomy (ELA) using the Spectranetics Turbo Elite Laser Ablation Catheter and the Spectranetics Turbo-Tandem Laser Guide Catheter with Laser Atherectomy Catheter with adjunctive percutaneous transluminal angioplasty (PTA) to PTA alone in the treatment of femoropopliteal bare nitinol in-stent restenosis (ISR). The objective of the EXCITE ISR trail is to gather data regarding the safety and effectiveness of performing ELA with PTA for the treatment of in-stent restenosis, at the time of procedure, and at follow-ups at 30 days, six (6) months, and 12 months after the procedure. These results will be compared to treatment with PTA alone.
Sponsor: Spectranetics Corporation
Principal Investigator: Frank T. Bunch, MD, FACC, FSCAI
Coordinator: Mary Austin, RN, CCRC
IDENTIFY:
Build a repository of heart signals from eligible subjects. The collection of heart signals using Phase Signal Acquisition System are used to compare the results of CCTA to determine the everyday clinical use of the PSA in treatment and care along with early detection of heart disease.
Sponsor: CorVista Health
Principal Investigators: Jason H. Cole, MD, MSc, FACC
Coordinator: Lynn Ward, RN, CRC
Lutonix ISR
A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix (R) Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis. The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and occlusion or > 50% stenosis of a previously deployed bare nitinol stent(s) in the femoropopliteal artery that is appropriate for angioplasty. After successful protocol-defined pre-dilatation, subjects are randomized 2:1 to treatment with either the LUTONIX(R) Drug Coated Balloon (test arm) or standard Percutaneous Transluminal Angioplasty (PTA) Catheter (control arm). The primary safety and efficacy endpoint assessments are 12 months. Clinical follow-up continues through 2 years and telephone follow-up through 5 years.
Sponsor: Bard/Lutonix
Principal Investigator: Frank T. Bunch, MD, FACC, FSCAI
Coordinator: Mary Austin, RN, CCRC
LUX DX Trends Study:
The Lux-Dx Trends Study is an investigational IDE Study that uses and investigational version of commercially released Lux-Dx™ ICM. The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) system, the Lux-Dx™ ICM. Open to Enrollment.
Sponsor: Boston Scientific
Principal Investigators: E. Matthew Quin, MD, FACC
Sub-Investigators : Robert P. Robichaux Jr. MD, MPH, FACC and Jordan M. Chaisson MD, FACC, FHRS
Coordinator: Mary Austin RN, CRC
PRECISE: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms & Revascularization
Primary objective of the PRECISE trial is to assess clinical outcomes, decision making regarding non-invasive testing and invasive angiography, and costs using a precision evaluation strategy as compared to a usual care strategy in participants with stable symptoms suggestive of coronary artery disease. Closed for enrollment.
Sponsor: HeartFlow(R)
Principal Investigator: Jason H. Cole, MD, MSc, FACC
Coordinator: Lynn Ward, RN, CRC
SMART MSP
SMART MSP research study is to Evaluate the effectiveness of Boston Scientific’s left ventricular multisite pacing feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling. It is indicated for patients with heart failure who receive stable optimal pharmacologic therapy for heart failure.
Sponsor: Boston Scientific
Principal Investigator: E. Matthew Quin, MD, FACC
Coordinator: Ruth Wagner, RN, CRC, CRNP
TIGRIS
The purpose of this study is to determine the safety and effectiveness of the GORE TIGRIS Vascular Stent (called the "study stent"), compared to BARD LifeStent (called the "control stent"). The control stent is the only stent approved by the Food and Drug Administration (FDA) for treating patients with obstructive peripheral artery disease (PAD), while the study stent is still in research studies in the US. The study stent has been approved for use elsewhere in the world. In this study, patients will be randomized in a 3:1 design to placement of either Tigris or LifeStent.
Sponsor: W. L. Gore
Principal Investigator: Frank T. Bunch, MD, FACC, FSCAI
Coordinator: Mary Austin, RN, CCRC
TRANSCEND
The objective of TRANSCEND is to demonstrate the safety and efficacy of the Surveil Drug Coated Balloon (DCB) for the treatment of subjects with symptomatic peripheral artery disease, PAD, due to stenosis of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 with either the Surveil DCB or the IN.PACT Admiral DCB and followed for 60 months.
Sponsor: Surmodics
Principal Investigator: Frank T. Bunch MD, FACC, FSCAI
Coordinator: Mary Austin, RN, CCRC
WARRIOR:
A Women’s Ischemia Trial that is multicenter, prospective, randomized, blinded outcome evaluation of symptomatic women with ischemia but no obstructive Coronary Artery Disease (CAD). This study is being conducted to determine whether aggressive medication treatment to modify risk factors in women with Coronary Arteries showing no severe obstruction but with cardiac symptoms will reduce their likelihood of dying, having a heart attack, stroke or being hospitalized. The results of this study will provide the data necessary to inform future guidelines regarding how best to treat this growing population of women, and ultimately improve their cardiac health and quality of life and reduce health care costs.
Sponsor: University of Florida Health
Principal Investigator: Jason H. Cole, MD, MSc, FACC
Sub- Investigator: Ruth Wagner, CRNP
Coordinator: Lynn Ward, RN, CRC