Pemberton Township

Researchers are evaluating the effect of ataciguat on slowing the progression of moderate calcific aortic valve stenosis (CAVS) in adults. This study is divided into two parts: Part A focuses on whether ataciguat reduces aortic valve calcium buildup, and Part B investigates whether ataciguat slows loss of aortic valve area and improves peak oxygen consumption. The study also assesses safety, tolerability, and pharmacokinetics of ataciguat in these participants. Participants will receive either ataciguat or a placebo daily for up to 156 weeks. Part A will enroll about 132 adults with moderate CAVS, while Part B will enroll approximately 1144 participants following completion of Part A. The study is randomized, double-blinded, and placebo-controlled, designed to provide detailed information on ataciguat's effects over time. Throughout the study, participants will undergo non-contrast CT scans to measure aortic valve calcium, echocardiograms to assess valve area, and cardiopulmonary exercise testing to evaluate peak oxygen consumption. Safety and tolerability will be monitored continuously. The primary outcomes include changes in aortic valve calcium at 24 weeks, and changes in aortic valve area and peak oxygen consumption at 48 weeks, with long-term participation lasting up to 156 weeks.

This research aims to evaluate the long-term safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure. It is a global, observational study that includes patients who have received or will receive CCM therapy using an Impulse Dynamics system, including future CCM technologies such as CCM-D. The study combines both prospective and retrospective data collection to better understand CCM therapy in everyday medical practice. Participants in this single-arm study will be followed over a period of at least five years. The study does not involve experimental treatments but observes patients who have undergone CCM device implantation as part of their heart failure management. The registry includes ongoing monitoring of device performance and patient outcomes using the available CCM technologies. During the study, researchers will assess the frequency and duration of hospital stays related to heart failure over one year and monitor device- or procedure-related complications over five years to evaluate long-term safety. Participants will undergo regular follow-up visits where data on health status and any hospitalizations will be collected. The study aims to provide real-world insights into CCM therapy's impact on heart failure management and patient well-being.

Researchers are evaluating the safety and effectiveness of the AccuCinch Ventricular Restoration System in patients with heart failure who have a reduced ejection fraction, a condition where the heart does not pump blood efficiently. This international, randomized, open-label study involves patients diagnosed with heart failure and dilated cardiomyopathy, aiming to compare this device plus standard medical treatment against standard treatment alone. The study focuses on improving heart function and patient quality of life. Participants are randomly assigned to two groups: one receiving the AccuCinch device along with guideline-directed medical therapy, and the other receiving only the medical therapy. About 200 patients will be in each group. Medical treatments are optimized according to current heart failure guidelines. The study includes multiple assessments over time to monitor the device's impact and the patients' heart health. Throughout the study, participants will undergo various tests and evaluations including quality of life questionnaires, six-minute walk tests, and monitoring for major adverse events related to the device or femoral artery access. The study will track outcomes for up to 365 days, measuring deaths, heart failure hospitalizations, and changes in heart function scores. Participants must attend follow-up visits and comply with testing schedules to assess the safety and benefits of the treatment.

Researchers are collecting real-world data on the use of commercially available Boston Scientific drug-eluting devices for treating lesions in the peripheral blood vessels. This study aims to include patient populations not previously well represented in peripheral vascular disease trials and to gather health economic information to support the safe use of these devices. Participants will be treated with any eligible Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. These devices are used to treat lesions located in the peripheral vasculature. The study is global, prospective, open-label, non-randomized, and involves multiple centers. During the study, researchers will monitor major adverse events and lesion patency over 12 months. Participants will be followed to assess the safety and effectiveness of the devices in real-world settings. Health economic data will also be collected to better understand the broader impact of these treatments.

Researchers are assessing the 30-day safety and effectiveness of the KARDION CORY P4 System for patients with coronary artery disease who need hemodynamic support during a high-risk percutaneous coronary intervention (PCI) procedure. This trial focuses on individuals with reduced left ventricular function and complex coronary artery conditions who are at high risk during PCI. The study aims to compare two types of percutaneous mechanical circulatory support devices to see how well they perform in supporting such high-risk patients. Participants are randomly assigned to receive one of the two mechanical circulatory support devices during their high-risk PCI procedure. The devices are inserted and used to support heart function throughout the intervention. The trial includes careful selection based on heart function, coronary artery disease complexity, and vascular access suitability. The study does not mention additional treatment phases beyond the PCI procedure and follow-up. During the study, participants will be monitored closely for major adverse cardiac and cerebrovascular events (MACCE) and device-related safety issues within 30 days after the procedure. Researchers will conduct assessments including imaging, blood tests, and clinical evaluations to track heart function, vascular health, and device performance. Participants must comply with follow-up visits and evaluations as specified in the protocol, which last at least 30 days post-procedure to capture safety and effectiveness outcomes.

This research aims to evaluate the effectiveness and safety of a sirolimus drug coated balloon (DCB) compared to standard balloon angioplasty in treating below-the-knee arterial disease. This condition, part of peripheral arterial disease (PAD), can lead to limb loss, and while drug coated balloons have shown benefits in other arterial areas, their effectiveness below the knee is less clear. The study is a pivotal, prospective, randomized, single-blind, placebo-controlled trial conducted across approximately 80 sites worldwide, with a significant number of participants recruited from the USA, Europe, Australia, and Asia. Participants will first undergo standard balloon angioplasty to prepare the arterial lesion. They will then be randomly assigned to one of two groups: one receiving the MagicTouch PTA sirolimus coated balloon catheter in addition to the standard angioplasty, and the other receiving a placebo balloon angioplasty alongside the standard procedure. Lesions treated are in the below-the-knee arteries, and treatment will follow successful lesion preparation with less than 30% residual narrowing. During the study, participants will be monitored for primary patency at 12 months, defined as freedom from vessel blockage, restenosis, repeat interventions, and major amputation. Safety will also be assessed through a composite endpoint at 6 months and 30 days, depending on the measure. The trial includes detailed evaluations of arterial lesions and runoff, and will track outcomes to assess the potential benefits and risks of the sirolimus coated balloon in this patient population.

Researchers are evaluating the safety and effectiveness of the Carillon Mitral Contour System (CMCS) in treating patients with heart failure who have functional mitral regurgitation (FMR). This is a prospective, randomized, double-blinded, sham-controlled clinical trial involving 300 participants across sites in the United States, Canada, and Europe. The study aims to compare the CMCS implant procedure with a control group receiving a sham procedure to assess improvements in heart function and safety over time. Participants will be randomly assigned to one of two groups: an intervention group receiving the Carillon implant, which is placed in the coronary vein to reshape the mitral valve and reduce leakage, or a control group undergoing a similar procedure without implant placement. Both groups will continue receiving guideline-directed heart failure medications. Before randomization, participants undergo echocardiographic, coronary angiogram, and venogram evaluations to confirm eligibility and anatomical suitability for the implant. After the procedure, participants will have follow-up visits at 1, 6, 12, 18, and 24 months to monitor safety, heart function, and clinical status. After 24 months, the study will be unblinded, and participants will continue with annual contacts and echocardiograms for an additional 3 years, totaling 5 years of monitoring. Primary outcomes include freedom from major adverse events at 12 months and a clinical composite measure of efficacy at 24 months.

Researchers are evaluating the Thor system in adults aged 18 years and older who have new, untreated calcified blockages in the arteries of their legs due to peripheral artery disease (PAD). The study aims to determine whether the Thor system is safe and effective in treating these lesions. Patients often experience leg pain during walking or rest caused by reduced blood flow, and this trial focuses on treating these specific types of arterial blockages. Participants will receive treatment using the Thor laser atherectomy system, which involves using laser energy to remove calcified plaque and modify calcium in the affected leg arteries. The procedure includes x-ray imaging of the leg arteries, and doctors may also use additional treatments such as angioplasty balloons, drug-coated balloons, stents, or clot filters if needed. There is no comparison group in this study, so all participants undergo the treatment with the Thor system. Participants will have a screening visit before the procedure, including medical history review, physical exams, blood flow tests, blood tests, and pregnancy testing if applicable. After treatment, patients will be monitored until discharge or up to 24 hours if they remain hospitalized. Follow-up visits will occur at 30 days, 6 months, and 12 months after treatment to assess medical status, leg blood flow via tests and ultrasound, walking ability, quality of life, and any adverse events. The total participation time is about one year, with enrollment expected to take up to two years across multiple U.S. sites.