View clinical trials related to Heart Septal Defects, Atrial.
Filter by:The interventional catheterization allows the percutaneous treatment of congenital heart diseases as the atrial septal defect (ASD). The examination is guided by the X-rays with stochastic side effects worrying at the child's. The software "Echonavigator" allows to merge the ultrasound image and fluoroscopic. This innovative software facilitates the procedures and reduce the irradiation time in some adult procedures. The aim of this study was to validate the image fusion in children.
The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).
This project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization. The investigators will measure interstitial colloid osmotic pressure, distribution of proteins and cytokines. The study hypothesis is that "Oedema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane".
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.
Volume overload due to left-to-right shunting in patients with atrial septal defect type secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular resistance can be assessed non-invasively using bicycle stress echocardiography. By measuring cardiac output and pulmonary artery pressures at different stages of exercise, a pressure-output plot can be obtained. The slope of the pressure-output plot reflects pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years, pulmonary vascular resistance was higher when compared to age-matched controls, indicating the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease pulmonary vascular resistance. The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD repair after the age of 40 years, administration of bosentan decreases pulmonary vascular resistance as assessed by bicycle stress echocardiography.
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery. Participants will be randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in it). Citrulline is a protein building block in the body that can convert into another substance, nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in the lungs can be an important surgical problem; it may also lead to problems following surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical ventilation. The objective of this study is to determine in a randomized placebo controlled phase IB multicenter clinical trial if a revised protocol of intravenous L-citrulline delivery given perioperatively achieves a plasma citrulline level of > 100 umol/L in children undergoing surgical repair of an atrial septal defect,ventricular septal defect or an atrioventricular septal defect.
The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding and is defined as a patent foramen ovale (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a material with superelastic properties, which, in its relaxed state, has the form of a double umbrella. This is a single-center, non-comparative, prospective interventional clinical investigation involving 1 center in Germany to assess the effectiveness, safety and practicability of implantation of the Nit-Occlud PFO® Closure Device.
The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).