Egg Harbor City

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating the safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy in people with heart failure who have a left ventricular ejection fraction (LVEF) between 40% and 70%. This clinical trial is prospective, multi-center, randomized, quadruple-blind, and sham-controlled, aiming to assess CCM therapy delivered through the OPTIMIZER Smart Mini System. The study is divided into two parts: Part I focuses on safety and effectiveness based on functional capacity and health status, while Part II focuses on clinical outcome data. Participants will have the OPTIMIZER Smart Mini System implanted and then be randomized in a 2:1 ratio to either have CCM therapy turned ON or OFF for the first 18 months, during which the trial is blinded. CCM therapy is programmed to deliver seven one-hour treatment phases evenly spaced over 24 hours. After 18 months, participants initially assigned to the CCM OFF (sham) group will have the therapy turned ON. Subjects enrolled in Part I will continue to be followed through Part II to contribute data for safety and effectiveness evaluation. Throughout the study, participants will undergo various assessments including the 6-minute walk test and the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score to measure changes in functional capacity and health status at 6 months. Safety will be monitored by tracking device- or procedure-related complications up to 12 months. The study also measures a composite of mortality, morbidity, and health status outcomes over an 18-month period. Follow-up and monitoring continue throughout the study duration to capture these outcomes and ensure participant safety.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

Researchers are evaluating inclisiran, a subcutaneous injection given twice yearly, to see if it can prevent major cardiovascular and limb events in patients undergoing percutaneous coronary or peripheral arterial revascularization. This Phase 4, randomized, double-blind study includes patients with symptomatic coronary artery disease or peripheral artery disease who have recently had successful revascularization procedures. The trial aims to assess the real-world effectiveness of inclisiran alongside usual care in a typical U.S. patient population with atherosclerotic cardiovascular disease. Participants will be randomly assigned to receive either 300 mg inclisiran or a matching placebo by subcutaneous injection on Day 1, Month 3, and then every 6 months thereafter. The first dose is given within 14 days of a successful percutaneous coronary or peripheral endovascular intervention. Both groups will continue to receive standard medical care as directed by their physicians. The study plans to enroll about 6,000 participants and treatment duration may last up to approximately 45 months. During the study, researchers will monitor participants for the occurrence of major adverse cardiovascular events and major adverse limb events for up to about 4 years. Participants will have regular follow-up visits and safety assessments throughout the study period, which is designed to continue until around 2,380 primary events have occurred or at least half the participants have completed 36 months of follow-up. Outcome measures focus on the number of cardiovascular and limb events after the procedures, providing important information on the long-term impact of inclisiran in this patient group.

Researchers are evaluating the safety and effectiveness of the MagicTouch™ sirolimus-coated balloon compared to plain balloon angioplasty (POBA) for treating coronary in-stent restenosis (ISR) in patients with prior drug-eluting stent (DES) implantation. This prospective, multicenter, randomized, single-blind trial aims to enroll about 492 subjects across up to 50 sites in the United States. The purpose is to establish whether the MagicTouch™ balloon offers improved treatment outcomes for narrowing inside previously placed coronary stents. Participants who qualify will be randomized in a 2:1 ratio to receive either the MagicTouch™ sirolimus-coated balloon or POBA. Before the procedure, medical history, physical exam, lab tests, and a 12-lead ECG will be performed within 7 days. Women of childbearing potential will have a pregnancy test. During the procedure, the assigned balloon treatment will be applied to the target ISR lesion. Blood samples will be collected before and after the intervention to measure cardiac biomarkers, with follow-up assessments to monitor heart injury. The trial includes detailed angiographic evaluations interpreted by a blinded core lab. After hospital discharge, participants will be followed for up to 60 months with assessments at 30 days, 6 months, 12 months, and annually thereafter. Follow-up visits will include ECGs, blood tests, and evaluations of adverse events and medications. Physicians will review angiograms to determine the need for additional treatments. The main outcome measured is Target Lesion Failure (TLF) at 12 months, reflecting the safety and efficacy of the treatments over time.

Researchers are evaluating the safety and effectiveness of the MagicTouch12 sirolimus-coated balloon for treating small blood vessels in patients with coronary artery disease. This pivotal, multicenter, randomized, single-blind trial involves about 1605 participants from up to 50 sites in North America, with additional sites in Europe and South America potentially contributing. The study aims to confirm the balloon's safety and efficacy in vessels 2.75 mm or smaller. Participants with small vessel coronary artery disease undergoing percutaneous coronary intervention will be randomly assigned in a 2:1 ratio to either the MagicTouch sirolimus-coated balloon or a drug-eluting stent. Treatment targets one lesion in a major coronary artery or side branch with vessel diameters under 2.75 mm and lesion lengths up to 34 mm. The control group will receive FDA-cleared drug-eluting stents, while the investigational group receives the MagicTouch balloon. Lesion preparation and treatment follow established medical guidelines. Participants will have medical history reviews, physical exams, lab tests, and ECGs before the procedure. Women of childbearing potential will have pregnancy tests. Patient-reported outcomes will be collected using the Seattle Angina Questionnaire at baseline, 30 days, 6 months, and 12 months. The main outcome measured is target lesion failure within 12 months. The study includes follow-up visits to monitor safety and treatment effects over one year.

Researchers are evaluating the LimFlow System, a device designed to create an arteriovenous (AV) connection in the below-the-knee vascular system using a minimally invasive, endovascular approach. The study focuses on patients with late-stage chronic limb-threatening ischemia who are not eligible for standard surgical or endovascular limb salvage procedures. This trial aims to gather additional information on the LimFlow System's use for arterializing pedal veins to treat this severe condition. Participants will receive treatment with the LimFlow Stent Graft System, which involves creating an arteriovenous fistula in the affected limb. The procedure is performed percutaneously to establish blood flow through the pedal veins. This is a prospective, single-arm, multi-center study without a comparison group, focusing on the safety and effectiveness of this device for this patient population. During the study, participants will be monitored for amputation-free survival over a six-month period. Assessments will include clinical evaluations, wound care monitoring, and follow-up visits to track healing and limb status. Researchers will also observe adverse events and overall patient outcomes related to the device and procedure. The total study duration for participants covers these six months of follow-up after the treatment.