Current Cardiology Clinical Trials

**For more information on clinical trials related to cardiomyopathy 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.

**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.

**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).

**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.

**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.

**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.

**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.

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 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.