View clinical trials related to Congenital Heart Defects.
Filter by:Children (ages 0-12) that have heart surgery are often at a high risk of developing complications and have to be continuously monitored. Part of the routine care at UCLA includes using a monitor (continuous central venous oxygen saturation-ScvO2) to measure the amount of oxygen saturation in the tissues (indirectly) during surgery and in the intensive care unit. However, there is not much data on the use and effectiveness of this monitor in comparison to other monitors used for children. The purpose of this study is to further evaluate the effectiveness of the continuous central venous oxygen saturation (ScvO2) monitor in children and compare it with other monitors during a heart surgery. This is an observational study and the patients will not undergo any research specific procedures in the operating room (OR). The investigators will observe and record de-identified information, such as vital signs (heart rate, blood pressure, etc.), to evaluate the importance of the monitor. This study will also look at the demographics (age, gender, diagnosis, etc.) and treatments (type of surgery) received children undergoing heart surgery to improve quality of care. The investigators will also observe the same parameters in the ICU. The investigators hypothesized that low central venous saturations are associated with worse clinical outcomes.
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
This study will examine genetic material obtained from blood and tissue samples of patients with congenital heart disease (CHD) and heterotaxy (an abnormality in the left-right positioning of organs in the body, also called situs inversus) to gain a better understanding of these disorders and of a lung disease called primary ciliary dyskinesia (PCD). CHD is prevalent in patients with heterotaxy. It is believed that certain forms of CHD or heterotaxy may have the same genetic origin as PCD. Individuals 2 years of age or older who have a CHD or heterotaxy or both may be eligible for this study. Participants undergo some or all of the following tests and procedures: - Blood tests, electrocardiogram (EGC) and chest x-ray. - Saliva collection: Subjects rinse their mouth with water, and then spit approximately 1.5 cc of saliva into a sterile container. - Buccal swabs: A small soft, toothbrush-like swab is rubbed on the inside lining of the cheek to collect tissue samples. - Nasal tests to measure nasal nitric oxide levels and to obtain tissue samples from the inside of the nostrils: For the nitric oxide level test, a rubber probe is inserted into one of the nostrils until it fits snugly and comfortably. The subject then takes a deep breath and then exhales all the way out through the mouth through a plastic device. During exhalation, gas measurements are recorded on a computer. To obtain tissue samples, a device is inserted in a nostril and scraped gently against the inside of the nose. - Echocardiography: This ultrasound test of the heart uses sound waves to obtain pictures of the heart. A small wand with a warm clear gel is moved around the chest to obtain the images. - Abdominal ultrasound: This ultrasound test of the heart uses sound waves to obtain pictures of the abdominal organs. A small wand with a warm clear gel is moved around the abdomen to obtain the images....
The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing, which is the main group in this study. Optional: Immediately after implantation the patients are divided into group A and B (randomized, single blind (for the patient), cross-over design). The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward. At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed. Subjective quality of life assessment (questionnaire) will also be performed at the defined follow-up intervals, and if applicable (optional) also objective assessment of the physical performance (VO2 max). 55 patients also including children and adults with CHD are planned to be included in the study. The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function (ejection fraction and QRS interval).
The current method of evaluating the surgical repair during surgery is limited to echocardiography (a noninvasive diagnostic procedure that uses ultrasound to study the structure and motions of the heart) or an invasive procedure called cardiac catheterization. The SPY imaging system makes use of the fluorescence properties of indocyanine green (ICG) to obtain high quality images in blood vessels. ICG is a green dye used to test heart output. The use of the SPY imaging system during surgery may provide valuable information regarding successful vessel connection and the area remaining unblocked. This study will compare the results of images to echocardiography and conventional angiography results. With SPY imaging, congenital heart surgeons would be able to check the quality of the procedure and revise, redo or perform additional procedures as dictated by the images before the patient leaves the operating room.
Malformations of the heart (congenital heart disease) are the most common congenital birth defects, occurring in about 1% of children. Each year, between 150-200 children will undergo open heart surgery at British Columbia Children's Hospital (BCCH) to repair the defect(s) in their heart. The abnormal structure of the heart or the open heart surgery may cause damage to the electrical system of the heart which can disturb the rhythm of the heart (arrhythmias), prolong recovery or be life-threatening. For this reason, temporary pacing wires are placed in the heart following surgery to ensure the heart rhythm is as normal as possible during the post-operative period (pacing). In recent years, scientists have recognized that pacing the heart from one area is not necessarily the same as pacing it from a different area. In fact, in some individuals with arrhythmias and poor heart function, pacing the heart from different areas can improve the pumping of the heart, resulting in better heart function. This form of treatment is called Cardiac Resynchronization Therapy (CRT) because it endeavours to optimize the pumping of the heart by changing the electrical activation of the heart. CRT has been used to a very limited extent in children. A few pediatric cardiologists have used CRT to help children who are in heart failure. We would like to determine whether pacing the heart from different areas after open heart surgery improves the child's heart function and aids his or her recovery.
Usually, "heart failure" refers to myocardial insufficiency of the left ventricle. However, in patients with congenital heart defects, often predominantly the right ventricle is affected. Brain natriuretic peptide (BNP) has been shown to be a reliable biomarker for left ventricular function and severity of left ventricular failure. The objective of the present investigation is to evaluate brain natriuretic peptide (BNP) with regard to its predictive value as a biomarker for right ventricular function, clinical symptoms and/or the patients' quality of life.To this end, blood levels of neurohumoral markers are measured and tested for statistical correlation with exercise tolerance and right ventricular function, as assessed by imaging methods. A sample of healthy volunteers serves as a control group.
We conducted a multicenter, randomized, placebo-controlled trial of Cylexin, an inhibitor of the attachment of white blood cells to the endothelium. Our study population was neonates and infants undergoing hypothermic cardiopulmonary bypass during surgical repair or palliation of congenital heart defects.
PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet aggregation similar to adults.
This study is a prospective, randomized study of patients with single ventricle heart disease who are to undergo superior cavo-pulmonary anastomosis, or "Glenn" operation. Such patients have historically undergone cardiac catheterization to ensure suitability for the procedure. Cardiac magnetic resonance imaging (cardiac MRI) is a newer technology that provides excellent anatomic and functional imaging of the heart. This study is designed to demonstrate our hypothesis that cardiac magnetic resonance imaging will provide comparable information to catheterization, with less side effects.