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Current Cardiology Clinical Trials

Research plays a crucial role in improving the health of current and future generations. Participation from volunteers ensures there are ongoing advances in the medical field. Click on any of the following links to see a list of currently enrolling clinical trials for each disease/condition:

**For more information on clinical trials related to cardiac arrhythmias call 843-792-2944

  • Manage-HF Multiple cArdiac seNsors for mAnaGEment of Heart Failure

MANAGE–HF has two objectives and will fulfill the requirements of the post-approval study:

 1. To evaluate and optimize HeartLogic™ Heart Failure Diagnostics (HeartLogic) clinical integration and the alert management process (Phase I)

 2. To evaluate HeartLogic in regards to patient outcomes of death and heart failure hospitalizations (Phase II)

  • Stroke VT: Safety and Efficacy of Periprocedural Apixaban Use for Reduction of the Risk of Cerebrovascular Events in Patients Undergoing Ventricular Tachycardia Radiofrequency Catheter Ablation.
    This is a multicenter, randomized, prospective study to determine if Apixaban can be used periprocedural in patients undergoing a scar VT ablation.
  • TactiSense: Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation

This clinical investigation is intended to demonstrate the acute safety of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF).

**For more information on clinical trials related to cardiomyopathy call 843-876-5011

  • DCM Precision Medicine Study
    Many people with dilated cardiomyopathy (DCM) have no discernible cause for their condition. This is called “idiopathic” DCM, or it may be attributed to an unknown possible virus. With improvements in technology, genetic testing is now capable of finding a genetic cause for DCM in 20-35% of people with this condition. The aims of the DCM Precision Medicine Study are to test the hypothesis that DCM has substantial genetic basis and to evaluate the effectiveness of a family communication intervention in improving the uptake and impact of family member clinical screening.

  • AG10 in Amyloid Cardiomyopathy
    Transthyretin Amyloid (also called ATTR) is a condition in which a protein becomes insoluble and deposits in the heart, resulting in congestive heart failure. ATTR is sometimes caused by DNA abnormalities in the TTR gene. This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK and PD of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening and randomization will be followed by a 28-day blinded, placebo-controlled treatment period.

  • ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy due to Lamin A/C Gene Mutation
    Inherited cardiomyopathy caused by abnormalities in the LMNA gene (encoding Lamin A/C) is characterized by high rates of heart failure and arrhythmia. This is a randomized, double-blind, placebo-controlled study in patients with dilated cardiomyopathy (DCM) due to LMNA mutation. The study will further evaluate a dose level of ARRY-371797 that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed, eligible patients may receive open-label treatment with ARRY-371797.

**For more information on clinical trials related to heart failure reduced ejection fraction call 843-876-5009

  • Grahf 2: Genomic Response Analysis of Heart Failure Therapy in African Americans
    It is well known heart failure remains a major cause of cardiovascular morbidity and mortality among African Americans. It is also known the effectiveness of certain heart failure therapeutics appears to be distinctively different in black and white cohorts. Based on previous studies, the response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. The purpose of this study is to see if African American with a specific genotype would benefit from this therapy. If so in the future it may be feasible to consider customizing medication therapy to improve outcomes in this patient population.
     

  • INVESTEDINfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure
    INVESTED is a multi-site trial comparing high-dose (60 μg per vaccine viral strain) trivalent influenza vaccine to standard-dose (15 μg per viral strain) quadrivalent influenza vaccination for up to three influenza seasons in high-risk cardiovascular disease patients with a history of myocardial infarction in the previous 12 months OR history of heart failure hospitalization in the previous 24 months. Subjects will be randomly assigned to receive either the high-dose or standard-dose vaccine. 
     

  • Momentum 3 CAP: Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3 Continued Access Protocol
    This study is comparing a newer left ventricular assist system called the HeartMate III to the currently available HeartMate II system in patients with advanced left ventricular heart failure. A left ventricular assist system is designed to provide hemodynamic support either for a short period of time, such as while waiting for a heart transplant, or for a longer period of time when other treatment options are not enough. The purpose of this MOMENTUM 3 Continued Access Protocol (CAP) is to continue to collect data on the HeartMate 3 while the FDA is reviewing study results of the MOMENTUM 3 trial. The MOMENTUM 3 study has completed enrollment and the FDA is now reviewing safety and performance data.
     

  • PIONEER-HF:  Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Enalapril on Changes in NT-proBNP and Safety and Tolerability of In-hospital Initiation of LCZ696 Compared to Enalapril in HFrEF Patients Who Have Been Stabilized Following Hospitalization for Acute Decompensated Heart Failure
    The primary objective of this study is to assess the effect of initiating sacubitril and valsartan tablets (Entresto) vs. enalapril in patients who are admitted with decompensated congestive heart failure by measuring changes in NT-proBNP levels during the course of the study. Potential patients are those with a history of heart failure with a weakened heart muscle. Once enrolled subjects will be randomized to receive either sacubitril and valsartan or enalapril and will take along with their other regularly prescribed medications. Subjects will have 9 visits of a period of 12 weeks, the first 8 weeks they do not know which treatment they are receiving but the final four weeks all subject receive the sacubitril and valsartan. Each study visit will take about 90 minutes. Study medication and study related treatment will be provided at no extra cost to the subject.
     

  • BeAT-HF: Barostim neo - Baroreflex Activation Therapy for Heart Failure. 
    The purpose of this study is to show whether the Barostim Neo system is safe and works in people with heart failure. The device is designed to stimulate the body's natural cardiovascular regulators in your neck to potentially improve your heart failure condition. Learn more about the CVRx Barostim neo device.
     

  • BMS Infusion: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients with Heart Failure and Impaired Systolic Function
    The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986231in subjects with heart failure (HF) and reduced systolic function (LVEF < 40%)="" who="" are="" admitted="" to="" the="" hospital="" with="" signs="" and="" symptoms="" of="" acute="" decompensated="" heart="" failure="">
     

  • LYFT-HF: Lymphangiogenesis Factors in Heart Failure States
    This study will investigate the blood levels of various proteins to see if we can figure out how the lymph vessels of people with long-standing heart failure might grow.

     

  • GALACTIC: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mercarbil on Mortality and Morbidity in Subjects with Chronic Heart Failure with Reduced Ejection Fraction
    To evaluate the effect of treatment with omecamtiv mercarbil (OM) compared with placebo on the time to cardiovasular (CV) death of first HF event, whichever occurs first, in subjects with chronic HF with reduced ejection fration (HFrEF) receiving standard of care (SOC) therapy
     

  • HELP - Hemodynamic Effects of Biventricular Pacing in LVAD Patients
    A study looking at the acute hemodynamic effects of different pacing modalities in LVAD patients with a biventricular pacemaker.
     

  • SOPRANO: Pulmonary hypertension post-left ventricular assist device implantation
    To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.

     

  • SOLVE-CRT: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-responders and Previously Untreatable Patients
    This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal trial to study the safety and efficacy of the WiSE-LV System for Cardiac Re-synchronization Therapy.

**For more information on clinical trials related to heart failure preserved ejection fraction call 843-792-1238

  • REDUCE LAP-HF: A study to evaluate the Corvia Medical, Inc. IASD System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
    The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the investigational device in the treatment of patients with heart failure symptoms and relatively normal pumping of the heart. The device is called the IASD system II and it is permanently implanted in the heart to reduce in the increased pressure by creating a small opening between the two upper chambers of the heart. Learn more about the Corvia Medical, Inc. IASD System II.
     

  • Regress-HFpEF: Regression of fibrosis & reversal of diastolic dysfunction in HFPEF patients treated with allogeneic CDCs (“Regress-HFPEF”)  
    This study is evaluating an investigational product called CAP-1002 Allogenic Cardiosphere –Derived Cells. Allogenic means tissue or cells that come from another person. CAP-1002 is a product consisting of cells grown from donated heart muscle tissue. The purpose of this study is to look at the safety and feasibility of delivery of allogenic human cardiosphere derived stem cells (CDC’s) through the arteries of the heart in participants with heart failure. The study will also determine if CAP-1002 might reduce clinically-meaningful adverse events, meaning some of the symptoms you are experiencing relating to your heart failure may go away and you may feel better. In this study, we will be investigating whether CAP-1002 is safe and begin to look at effectiveness in repairing heart tissue in comparison to placebo (inactive substance) control.

**For more information on clinical trials related to high cholesterol call 843-792-5863

  • CAscade-FH: Cascade Screening for Awareness and Detection of Familial Hypercholesterolemia
    The CASCADE FH Registry is a national, multi‐center initiative that will track the therapy, clinical outcomes, and patient‐reported outcomes over time. The Registry represents collaboration between The FH Foundation, lipid specialists, cardiologists, primary care providers, quality improvement personnel, and patients, all aiming to increase FH awareness, promote optimal disease management, and improve FH outcomes. The Duke Clinical Research Institute will help operationalize the clinical portal of the CASCADE FH Registry. The Registry will use a hybrid enrollment design to maximize outreach and ensure that all interested FH patients have the option to participate.
     

  • Clear Outcomes: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at High Risk For, Cardiovascular Disease Who Are Statin Intolerant
    The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

**For more information on clinical trials related to hypertension call 843-876-5009

  • Radiance-HTN: A study of the ReCor Medical Paradise System in Clinical Hypertension
    This is a clinical study looking at the effectiveness and safety of a new device call The Paradise System to use for renal denervation in patients who have mild to resistant hypertension. The study is divided into two groups, those on one to two anti hypertensive medications and those on three or more. For those only taking one or two medications, they will stop their current blood pressure medication while monitoring their blood pressure. Those who are taking 3 or more blood pressure medications will stop their current medication regime and be given one of two combination medications while monitoring their blood pressure. The goal of the renal denervation is to lower blood pressure by using ultrasound waves to heat and disable the nerves surrounding the blood vessels leading to the kidneys. It is believed these nerves may be too active in patients with high blood pressure.
     

  • ROX: A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects with Hypertension
    To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliacartery and vein) in subjects with hypertension.

**For more information on clinical trials related to implantable devices call 843-792-2944

  • Amulet: AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial
    The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the Amulet device is safe and effective when compared to another LAA closure device made by another medical device company named Boston Scientific. The other device, called the WATCHMAN LAA closure device, is approved for use in the United States and many countries in Europe, Australia, and other nations.  It is implanted in some patients with non-valvular atrial fibrillation to reduce the risk of stroke.  The WATCHMAN device will be used as the Control device in this study.
     

  • AdaptResponse: Clinical Trial
    This study is being done to see if receiving electrical treatment from a cardiac resynchronization therapy (CRT) device with the AdaptivCRT (aCRT) programming feature is better than receiving electrical treatment from a CRT device with the standard method of CRT device programming in patients with heart failure. Subjects will receive an already approved CRT pacemaker or defibrillator depending on what the doctor recommends. Approximately 3000 subjects will be enrolled at up to 200 centers around the world.
     

  • SMART CRT: Strategic MAnagement to Optimize Response TCardiac Resynchronization Therapy
    A prospective, double-blind, multicenter, international, randomized controlled trial. The primary objective is to show the benefit of SmartDelay™ in patients with a prolonged RV-LV interval.

**For more information on clinical trials related to peripheral vascular disease call 843-876-5011 

**For more information on clinical trials related to pulmonary embolism call 843-792-5863

  • PERT Registry: Pulmonary Embolism Response Team (PERT) Consortium Registry
    This registry is intended to gather data on patients diagnosed with pulmonary embolism, treated by the Pulmonary Embolism Response Team (PERT) at MUSC for epidemiologic, therapeutic, quality assessment and outcomes research. The PERT registry is will advance our understanding of practices used and outcomes of PE treatment modalities and drive future comparative research in the field.

**For more information on clinical trials related to valvular disease call 843-876-0940

  • COapt: Cardiovascular Outcomes Assessment of the MitraClip PercutaneousTherapy for Heart Failure Patients With Functional Mitral Regurgitation  
    To evaluate the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in symptomatic heart failure patients who are not candidates for mitral valve surgery.
    COapt Continued Access Study
    After the enrollment of the COAPT RCT is complete,COAPT CAS will provide the opportunity to continue the evaluation of the safety and effectiveness of the MitraClip® NT System in patients who meet the COAPT inclusion/exclusion criteria. This single arm registry will provide valuable new information regarding use of the MitraClip® NT System under more “real world” conditions.
     

  • Low-Risk TAVR: Transcatheter Aortic Valve Replacement with the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
    The CoreValve System and Evolut R have both been approved by the Food and Drug Administration (FDA) for use in patients who are at high and extreme risk for surgical aortic valve replacement (SAVR). This means that CoreValve and Evolut R are commercially available for use in patients who are deemed high or extreme risk for SAVR by their doctor. However, CoreValve and Evolut R have not been approved by the FDA for use in patients who are at low risk for SAVR. Therefore, the CoreValve System and Evolut R System are considered “investigational devices” in this low risk patient population and research studies are required to determine if they are safe, and provide clinical benefit.