Pemberton Township

Researchers are evaluating whether ataciguat can slow the progression of moderate calcific aortic valve stenosis CAVS in adults aged 50 and older. This study is conducted in two parts Part A focuses on whether ataciguat reduces calcium buildup in the aortic valve over 24 weeks, while Part B examines if the drug slows narrowing of the valve area and improves peak oxygen consumption over 48 weeks. Safety, tolerability, and how the body processes ataciguat are also assessed. Participants receive either ataciguat or a placebo daily for up to 156 weeks. Part A enrolls about 132 participants, and Part B will begin after Part A completes, enrolling around 1144 participants. Part B includes additional evaluation of heart function and ability to exercise. The study uses a randomized, double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. During the study, participants undergo imaging tests like CT scans and echocardiograms to measure valve calcium and valve area. Cardiopulmonary exercise testing CPET is used to assess peak oxygen consumption. Researchers also monitor heart function, symptoms, and quality of life using questionnaires. Assessments occur mainly at baseline, Week 24, and Week 48, with long-term follow-up to 156 weeks for safety and efficacy. The studys total duration extends to 2030.

Researchers are investigating the long-term safety and effectiveness of Cardiac Contractility Modulation CCM therapy in people with heart failure. This global study combines both past and future patient data to observe how CCM therapy, delivered through Impulse Dynamics devices, performs in real-world settings over extended periods. The goal is to better understand CCM therapys impact on heart failure outcomes and any related device or procedure complications. The study includes patients who have already received or will receive CCM therapy using Impulse Dynamics systems, including future technologies like CCM-D. It is a single-arm observational study without experimental treatment groups, following patients for at least five years after their therapy. Patients are grouped into prospective, retrospective, and hybrid cohorts based on when they receive or received the CCM therapy. Participants will be monitored through regular follow-ups to assess hospitalization rates and length of stay due to heart failure, safety regarding device-related complications, and various clinical outcomes such as mortality, functional capacity, and heart remodeling. Additional evaluations include quality of life measurements using the Kansas City Cardiomyopathy Questionnaire and assessments of therapy compliance. The study duration allows detailed observation of CCM therapy effects and patient health over several years, up to at least five years.

Researchers are collecting Real-World Data to better understand treatment outcomes and health economics related to lesions in the peripheral vasculature. This global, prospective, non-randomized, open-label, multi-center Registry aims to include populations not well represented in previous Peripheral Vascular Disease trials. The study supports the safe use of commercially available Boston Scientific drug-eluting devices for this condition. Participants receive treatment using any eligible commercially available Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. The study includes two cohorts a Clinical Cohort, where patients undergo standard of care assessments with follow-up for up to 2 years in multiple countries and 5 years in China, and an Outcomes Cohort at select sites with additional evaluations including Quality of Life questionnaires, six-minute walk tests, and healthcare utilization data collection. During the study, participants complete various assessments according to standard care and additional tests depending on their cohort. Researchers measure major adverse events and lesion patency at 12 months to evaluate outcomes. The study monitors participants through follow-up visits extending up to 5 years to gather safety and effectiveness data in real-world clinical practice.

Researchers are evaluating the safety and effectiveness of the KARDION Cory P4 System in adults aged 18 to 90 years who require hemodynamic support during high-risk percutaneous coronary intervention PCI procedures for coronary artery disease. The trial aims to demonstrate outcomes within 30 days after the procedure, focusing on major adverse cardiac and cerebrovascular events MACCE and device-related safety. Participants are randomly assigned to receive one of two types of percutaneous mechanical circulatory support devices during the PCI procedure. The study compares the KARDION Cory P4 System with a commercial control device. Treatment is provided during the index PCI procedure, and follow-up continues for 30 days to assess technical and procedural success as well as any device-related adverse events. During the study, participants undergo evaluations including safety monitoring and outcome assessments up to 30 days post-procedure. Researchers measure device-related safety, major adverse cardiac events, death, and other health outcomes related to the intervention. Participants must comply with follow-up visits and evaluations as specified in the study protocol. The total participation duration includes the procedure and a 30-day follow-up period.

Researchers are evaluating the effectiveness and safety of a sirolimus drug coated balloon compared to standard balloon angioplasty for treating below the knee arterial disease. This pivotal, prospective, randomized, two-arm, placebo-controlled trial will be conducted at about 80 sites worldwide, including the USA, Europe, Australia, and Asia. The study addresses the high burden of limb loss caused by peripheral arterial disease and explores sirolimus as an alternative to paclitaxel for drug coated balloons below the knee. Participants will be randomly assigned in equal groups to receive either the MagicTouch PTA sirolimus coated balloon catheter plus standard balloon angioplasty or a placebo balloon angioplasty plus standard balloon angioplasty. All patients first receive pre-dilation with a standard balloon angioplasty. The sirolimus coated balloon is used as an additional treatment after successful lesion preparation. The trial is single-blind and multicenter, aiming to compare outcomes between these two treated groups. During the study, participants will undergo assessments including angiographic evaluations and monitoring of limb health. The primary outcome is primary patency at 12 months, defined by freedom from vessel occlusion, restenosis, target lesion revascularization, and major amputation. Safety will also be evaluated at 6 months and 30 days with composite endpoints. Secondary outcomes include various safety and efficacy measurements up to 60 months. This comprehensive follow-up will help assess long-term treatment effects and participant safety throughout the study period.

Researchers are evaluating the safety and performance of the Conformal CLAAS device compared to the commercially available WATCHMAN and Amulet left atrial appendage closure devices in patients with non-valvular atrial fibrillation at high risk of stroke. The study aims to establish that the CLAAS device is not worse than these other devices in preventing stroke and related complications. Participants eligible for the study will be randomized to receive either the CLAAS device or one of the comparator devices and will be followed for a total of five years after implantation. Participants will undergo a procedure to implant one of the left atrial appendage closure devices via a catheter-based system. The study includes two groups one receiving the CLAAS device and the other receiving either the WATCHMAN or Amulet device. After implantation, patients will be monitored closely for safety and effectiveness outcomes, including procedure-related complications and stroke prevention over time. The study involves careful follow-up visits and assessments to track device success and any adverse events. Throughout the study, participants will have regular evaluations to monitor outcomes such as procedure complications, death, major bleeding, ischemic stroke, and systemic embolism, with primary outcome assessments at 12 and 18 months and extended follow-up up to five years. Success of the device placement and technical performance will also be assessed at various time points. Participants will be asked to follow medication regimens and attend follow-up visits to ensure proper monitoring. The total duration of participation includes post-procedure monitoring and long-term outcome measurement extending to the end of the study period.

Researchers are evaluating the safety and effectiveness of the Carillon Mitral Contour System CMCS in treating patients with heart failure who also have functional mitral regurgitation FMR. This prospective, randomized, double-blinded, sham-controlled trial aims to better understand how this device may impact heart function and symptoms in people with this condition. Participants will be randomly assigned to one of two groups one group will receive the Carillon implant along with guideline-directed heart failure medications, while the other group will receive only the heart failure medications and a sham procedure to preserve blinding. Before randomization, patients will undergo specific heart imaging tests and evaluations to determine eligibility and suitability for the device placement. After the procedure, participants will have follow-up visits at 1, 6, 12, 18, and 24 months to monitor safety and heart function. After 24 months, all participants will be informed of their group assignment and followed annually for an additional three years. During the study, researchers will assess various health outcomes including freedom from major adverse events at 12 months and clinical improvement at 24 months. Additional measures will include changes in heart valve function, heart size, walking ability, heart failure symptoms, hospitalizations, and quality of life. Participants will have regular heart imaging, clinical evaluations, and questionnaires to track these outcomes. The total participation time may extend up to five years with long-term monitoring to better understand the devices impact over time.

Researchers are evaluating the Thor system in adults aged 18 years and older who have new, untreated calcified blockages in leg arteries caused by peripheral artery disease PAD. The study aims to determine whether the Thor system is safe and effective for treating these lesions. Patients experience leg pain due to poor blood flow, and the study will observe how the Thor system works in this setting. All participants will receive treatment using the Thor laser atherectomy system, which targets calcified lesions to improve blood flow. During the procedure, doctors may also use additional devices such as angioplasty balloons, drug-coated balloons, stents, and clot-collecting filters if needed. The procedure includes x-ray imaging, and patients will be monitored closely until discharge or for up to 24 hours after treatment. Participants will have follow-up visits at discharge, 30 days, 6 months, and 12 months after the procedure. These visits include medical history reviews, physical exams of the legs, blood flow tests using arm and leg blood pressure comparisons, ultrasound imaging, and questionnaires about walking ability and quality of life. The study will measure outcomes such as freedom from major adverse events, procedural success, lesion openness, and improvements in walking and health surveys over one year.