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Find 437 clinical trials for heart disease near Dallas, Texas. Connect with research centers in your area.
Showing 61-80 of 437 trials
NCT06080074
There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children. 2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial The main questions the Cardiohelp single-arm trial seeks to answer are: * What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? * Should the Cardiohelp device be FDA-cleared for children based on the results of the study? * What are the optimal performance specifications of the Cardiohelp device in children? The main questions the blood thinner randomized trial seeks to answer are: * Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device? * How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner? Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications. For the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount of bleeding and clotting will be measured. The study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).
NCT02070315
Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM Elastography may provide a non-invasive, fast, and reproducible alternative for the quantitative assessment of liver fibrosis.
NCT05839730
FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States. Data will be collected to evaluate whether pacing therapies can lead to improvements in exercise capacity and health status of subjects.
NCT07050264
Burn survivors have difficulty thermoregulating due to reduced skin blood flow and sweating responses at the grafted sites. It has been previously shown that this impaired heat dissipation results in burn survivors experiencing higher core temperatures for a given exercise/environmental exposure compared to non-burned individuals. This also holds true with the use of simulated burn injury. When an absorbent material is applied to the skin over a desired amount of body surface area, it replicates a burn injury of the same size (i.e., simulated burn injury). A question that remains unknown is if this impaired thermoregulation in burn survivors would affect post-exercise core temperature recovery, i.e., do burn survivors recover slower than non-burned individuals upon stopping exercise. To that end, the primary objective of this project is to determine the rate at which body temperature and other markers of thermoregulation recover after a bout of exercise in the heat and if this response is different in the same individual with and without simulated burn injury.
NCT03383419
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
NCT05064709
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
NCT07018297
This will be a prospective, cluster-randomized, crossover, non-inferiority trial of 250 participants within 48 hours of an inpatient admission for heart failure or emergency department presentation for heart failure with plans for admission or observation/short-stay hospitalization comparing early discharge using subcutaneous furosemide to standard inpatient care. Individual practice groups will serve as "clusters" and the unit of randomization. Each participating cluster will implement either the early discharge strategy using the intervention or standard care for initial two-month blocks, followed by a crossover to the alternate strategy. The primary outcome is days alive and out of hospital at 30 days.
NCT05268094
COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.
NCT03229538
This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled safety and efficacy study. Blood samples will be collected from a subset of enrolled study participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will be followed for primary and secondary outcomes for the duration of their hospitalization. Serious study drug-related adverse events will be collected for 7 days after the last dose of study drug.
NCT06118281
The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.
NCT05093933
The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.
NCT07000123
This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated LDL-C. AZD0780 is a small molecule that reduces the amount of LDL-C in the blood. Placebo will be used for comparison, and neither the participants nor the Investigators will know who is receiving the AZD0780 medication and who is receiving the placebo until the end of study. The total length of the study for an individual participant will be up to approximately 56 weeks, including a screening period of up to 14 days, treatment with AZD0780 or placebo for 52 weeks, and a safety follow-up period of 10 days.
NCT05755711
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
NCT04452149
The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study. The purpose of the study is to demonstrate the safety and efficacy of a patient management pathway that utilizes an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure, and to demonstrate the safety of the Reveal LINQ™ system and procedure in the study population.
NCT03168776
The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents. This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to 1632 subjects at up to 130 investigational sites in North America, Japan, and Europe. Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years.
NCT05907564
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
NCT07335510
This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.
NCT04147884
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
NCT05253677
Computed tomography (CT) has become an established tool in the diagnostic workup of patients with suspected coronary artery disease (CAD). The availability of coronary CT angiography (CCTA) before the invasive procedure allows stratifying case complexity and can be used to improve patient selection for PCI, to plan and guide therapeutic interventions. Beyond the diagnostic and therapeutic phase, it helps to better organize the catheterization laboratory workflow. The P4 study is an investigator-initiated, multicenter, randomized study with a non-inferiority design of patients with an indication for PCI aiming at comparing clinical outcomes between two imaging strategies to guide PCI, being coronary CT-guided PCI strategy (investigational technology) and IVUS-guided PCI strategy (comparator). After identifying the presence of a significant coronary stenosis, the patient will be randomized either to CT- or IVUS-guided PCI groups. Both CT and IVUS-guided PCI will be performed following the P4 trial protocol. When the procedure is completed, post-PCI FFR will be measured. All patients will be followed in hospital, at 30 days (±15 days), 12 months (±1 month) and yearly until 5 year.
NCT05831085
The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and three-vessel CAD (not involving left main).
