Cardiology Clinical Trials

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

DIAMOND-AF II STUDY: A Prospective Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Persistent Atrial Fibrillation.
The objective of this study is to demonstrate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation.  It is a prospective, multi-center trial being performed at centers in the United States, Canada and Europe.

LESS-VT: FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT (LESS-VT) Study. This is a regulated, prospective, multi-center trial designed to evaluate the safety and effectiveness of the FlexAbility SE Catheter to obtain an indication to treat MMVT in the US. The clinical trial has two cohorts: one is a randomized ICM cohort and the second is a concurrent single-arm NICM cohort.

VISITAG: Evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA). The purpose of this study is to assess the safety and 12-month effectiveness of Tag Index-guided ablation using the THERMOCOOL SMARTTOUCH® SF (STSF) and the THERMOCOOL SMARTTOUCH® (ST) Catheters with VISITAG SURPOINT™ Module with External Processing Unit for pulmonary vein isolation in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.

ARTESIA: Apixaban for the Reduction of Thrombo-embolism in Patients with Device-detected Sub-clinical Atrial Fibrillation. This is a prospective, randomized, parallel group, double-blind trial to determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.

PERSIST-END: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation. The objective of this clinical trial is to demonstrate that ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) is safe and effective for the treatment of drug refractory, symptomatic persistent atrial fibrillation when following standard electrophysiology mapping and radiofrequency ablation procedures.

ECG Belt: ECG Belt for CRT Response: The purpose is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters in line with the EHRA/HRS 2012 expert consensus statement.

AFIB-01 – Elshazly: A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation: This study's objective is to determine if electrical stimulation can safely reduce atrial fibrillation, which is an abnormal heart rhythm that begins in the top chambers of the heart. Electrical stimulation will be delivered to the wrists or in the ear.

**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.

Eidos AG10-301: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Cardiomyopathy (ATTRIBUTE-CM Trial). This prospective, randomized, multicenter, parallel-group study will evaluate the efficacy and safety of AG10 in symptomatic subjects compared to placebo, administered on a background of stable heart failure therapy. Screening and randomization will be followed by a total of 30 months of blinded, placebo-controlled treatment.

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.

IONIS – Judge: A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM): The purpose of this study is to evaluate the safety and effectiveness of ION-682884 and determine if it can help people with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). ION-682884 has been shown to reduce the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time

MyoKardia – Judge: An Open-Label, Exploratory Study of the Safety and Preliminary Efficacy of Danicamtiv in Stable Ambulatory Participants With Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants or Other Causalities: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (the levels of drug in the blood) and pharmacodynamics (the effect of the drug on your body) of the study drug, MYK-491, when administered orally twice a day for about one to two weeks. The study will recruit patients with an enlarged heart and weakened heart muscle not caused by heart damage from a heart attack or heart valve problem. Eligible patients must also have a specific genetic mutation called MHY7.

AG10-304- Judge: An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants with Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 Attribute-CM Trial: Amyloidosis (ATTR) Cardiomyopathy (CM) is a progressive, fatal disease in which amyloid deposits build up slowly, over the course of many years to cause organ damage. This study will continue to evaluate the safety and tolerability of a new drug called Acoramidis given to adult patients with symptomatic Transthyretin amyloid cardiomyopathy.

CARS - Griffin: A Multi-Site Collaborative Study for a Cardiac Amyloidosis Registry: This registry is an observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025. It is expected that the total patient population will be approximately 5000 patients.

Cardiac Amyloidosis Registry – Griffin: A Registry for People with Cardiac Amyloidosis: This research study aims to compile a database of patients with suspected or confirmed cardiac amyloidosis to investigate disease formation and uncommon presentations. Patients must be 18 years or older and have a referral by a specialist with a clinical suspicion. We aim to have the registry provide better data for analysis, improve awareness, and most importantly, diagnose this condition at earlier stages.

AG10-202 OLE - Judge: An Open-Label Extension and Safety Monitoring Study of Patients with Symptomatic Transthyretin Cardiomyopathy Who Have Completed the Phase II Study AG10-201: The purpose of this research is to test a new experimental drug called “AG10” made by Eidos Therapeutics, to find out if this new drug is safe and if it works to help patients with Amyloidosis Cardiomyopathy. This is a follow up of the AG10-201 study in which participants were randomized to either study drug or placebo.

**For more information on clinical trials related to coronary artery disease call 843-792-5863.

Multicenter Registry of Chronic Total Occlusion Interventions: The goal of this multi-center, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers.

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

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. 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.
Learn more about the CVRx Barostim neo device.

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.

SOLOIST: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SotagLiflozin on Clinical Outcomes in HemodynamIcally Stable Patients with Type 2 Diabetes POST Worsening Heart Failure.
The primary objectives are:  To demonstrate that sotagliflozin reduces CV mortality and morbidity (composite of CV death or HHF) compared to placebo in hemodynamically stable patients with T2D and HF with LVEF <>50%, after admission for WHF. To demonstrate that sotagliflozin reduces CV mortality and morbidity (composite of CV death or HHF) compared to placebo in hemodynamically stable patients with T2D and HF,irrespective of LVEF, after admission for WHF (total patient population).

Venus HF –Tedford: Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure - An Early Feasibility Study: The purpose of this study is to see if an investigational device called preCARDIA Intermittent Balloon Device can limit fluid overload in congested patients with advanced heart failure.

FASTR – Inampudi: Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve Decongestion Management System (DMS): This study will enroll participants who are hospitalized with decompensated heart failure. Heart failure is a condition in which the heart is not able to pump blood efficiently and as a result fluid can build up. The Repreive DMS is an instrument designed to automatically administer medications called diuretics to optimize fluid removal and improve your symptoms of heart failure.

Corcinch HF – Steinberg: Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle).

**For more information on clinical trials related to heart failure preserved ejection fraction call 843-876-5783.

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.
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.

TNX-LVO-04: A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with HeartFailure and Preserved Left Ventricular Ejection Fraction (PHHFpEF). The objective of this trial is to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects.

DELIVER: Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure. An International, Double-blind, Randomised Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF). This study is evaluating the use of dapagliflozin vs placebo in the treatment of people with heart failure with preserved ejection fraction. AstraZeneca is doing this research to find out if the new medication dapagliflozin will work and be safe for the treatment of heart failure in addition to standard therapy used for treatment of heart failure. The study is planned to go on for about 33 months and include 4700 patients from about 21 countries. This research study is carried out to see if dapagliflozin is effective in preventing worsening of heart failure and improving survival in patients with heart failure and preserved systolic function.

FASTR – Inampudi: Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve Decongestion Management System (DMS): This study will enroll participants who are hospitalized with decompensated heart failure. Heart failure is a condition in which the heart is not able to pump blood efficiently and as a result fluid can build up. The Repreive DMS is an instrument designed to automatically administer medications called diuretics to optimize fluid removal and improve your symptoms of heart failure.

**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. 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.

Radiance II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension. The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

RADIANCE CAP - Todoran: Continued Access Protocol (RADIANCE CAP) A study of the ReCor Medical Paradise System in Clinical Hypertension: The purpose of this study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The treatment delivered by the device, which is known as renal denervation, is a procedure where a catheter is placed inside the blood vessels (renal arteries) that go to the kidneys. Ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels.

REDUCED - Todoran: Clinical evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for renal denervation in patients with uncontrolled stage 2 hypertension: This study is seeking participants with uncontrolled high blood pressure despite taking blood pressure medications. TIVUS, or Therapeutic IntraVascular UltraSound (TIVUS™) System, is designed to denervate (deaden) the nerves surrounding the renal arteries (blood vessels going to the kidneys) as a way to help lower blood pressure.

Amgen Lipoprotein - Waring: A Multicenter, Cross-sectional Study to Characterize the Distribution of lipoprotein (a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD): This study is being done to learn more about Lipoprotein (a) (Lp (a) values in people with known history of Atherosclerotic Cardiovascular Disease (ASCVD). Lipoprotein (a) is a particle that carries cholesterol in the blood. ASCVD is a type of thickening or hardening of the arteries caused by a buildup of plaque in the walls of arteries. Plaque is made up of substances such as fats and cholesterol. Plaque can cause blockages in the arteries which could result in a heart attack. High levels of Lp(a) are directly associated with a higher risk of cardiovascular events such as heart attacks or aortic stenosis.

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

SMART CRT: Strategic Management to Optimize Response To Cardiac 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.

S-ICD - Gold: The efficacy of the Smart Pass filter to Reduce the Risk for inappropriate subcutaneous implantable cardioverter-defibrillator shocks from myopotential interference: This study is enrolling participants who are already implanted with a S-ICD device (Subcutaneous Implantable Cardioverter Defibrillator, which is a device designed to monitor heart rhythms and deliver a shock to the heart to stop life threatening heart rhythms), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals.

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

PEERLESS – Todoran: This study is for participants who have been diagnosed with a pulmonary embolism or PE. A PE is a blood clot in the lung. This study is comparing the FlowTriever Retrieval/Aspiration System to any commercially available Catheter Directed Thrombolysis system in participants who have a PE and undergo a procedure to remove the clot.

ALL IN - Van Bakel: Targeting Inflammation and Alloimmunity in Heart Transplant Recipients with Tocilizumab (ALL IN): This study is enrolling participants who are awaiting a heart transplant. The study is comparing standard post-transplant anti-rejection medications with or without the addition of the investigational medication tocilizumab. Tocilizumab is also known as Actemra, and is FDA approved for the treatment of Rheumatoid Arthritis as well as other inflammatory diseases.

**For more information on clinical trials related to valvular disease call 843-792-5863.

Low-Risk TAVR CAS: Transcatheter Aortic Valve Replacement with the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement Continued Access Trials. The continued access trial is a multi-center, prospective, non-randomized, interventional trial conducted in the United States. The primary objective is to characterize the composite event rate of all-cause mortality and all stroke at 1 year post procedure.

CLASP II TR – Amoroso: Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation: This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the PASCAL Transcatheter Valve Repair System will be used to treat the tricuspid regurgitation.

ACURATE – Steinberg: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR: This study is enrolling participants with severe aortic stenosis, which is narrowing of one of the heart valves. This condition reduces the amount of blood that can get to the body. The procedure to place the device, referred to as TAVR - transcatheter replacement of aortic valve is done in place of open heart surgery. In this study the ACURATE Aortic Valve System will be compared to two commercially available Aortic Valve Systems (valve replacement systems).

ALIGN-AR – Amoroso: A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients with Symptomatic, Severe Aortic Regurgitation (AR): The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart’s aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

High Life – Steinberg: An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System: This study is examining the use, safety and performance of an investigational, meaning not approved for commercial use or sale by the US Food and Drug Administration (FDA) device called Transcatheter Mitral Valve Replacement (TMVR). The TMVR is a device used to treat mitral valve disease in patients with heart failure (weakened heart muscle). The device is placed by a non-surgical approach using a delivery catheter (hollow tube) placed in your blood vessel at the top of your leg and directed up to your heart.