View clinical trials related to Heart Septal Defects, Atrial.
Filter by:Patients received a MitraClip procedure because of a leakiness of their mitral valves. During this procedure the atrioventricular valves were stuck together permanently via a clip which leads to a reduction of leakiness. As a result of this procedure a small hole remains at the cardiac septum which is called an atrial septal defect (ASD). In most cases the hole will close after a few weeks or months, but in many other cases not. Until now there is no exact data about the effect of this hole on the filling pressure in the heart or on the blood flow behaviour. So the aim of this study is a precise analysis of the blood flow mechanics during and after the MitraClip procedure to identify criteria to get more informations for a better strategy and regulation of the MitraClip procedure.
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
This study is designed to investigate the ability of pleth variability index (PVI) to non-invasively predict fluid responsiveness in mechanically ventilated children. Patients undergoing atrial septal defect (ASD) repair in the cardiac catheterization suite will be recruited for this study. These patients are ideal candidates because very few deviations will be made from standard clinical practice. All patients will already be under general anesthesia, mechanically ventilated, monitored with pulse oximetry, and provided with intravenous fluid to compensate for their nil per os (NPO) fluid deficit. The only deviation from clinical practice will include an abbreviated echocardiographic exam, application of the Masimo pulse oximeter, and measurement of CO via a thermodilution catheter by the interventional cardiologist.
The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.
Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is useful for evaluation of defect size and shape. The investigators suggested optimal device size using three-dimensional transesophageal echocardiographic image and our formula in previous study. Purpose: In this study, the investigators seek to predict the correct device size and confirm the accuracy of the formula that we made before device closure in ASD patients.
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).
The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to the results of transesophageal echocardiography (TEE). RLS intracardiac shunts are associated with a number of clinically important syndromes including paradoxical thromboembolism (causing stroke or other systemic infarct), migraine headaches (particularly with aura), desaturation with obstructive sleep apnea, and decompression illness. From a research perspective, the detection of shunts in subjects with these types of syndromes is critical in helping to define the role of RLS in these disease processes. From a clinical perspective, shunt detection will be increasingly important in an era where interventional procedures for repairing cardiac defects are available for subjects determined to be at risk. The currently accepted reference standard for detection of an intra-cardiac patent foramen ovale/atrial septal defect (PFO/ASD) RLS is a transesophageal echocardiography (TEE), a procedure that is invasive, uncomfortable, and requires conscious sedation. Alternative options include transthoracic echocardiography (TTE) with injection of agitated saline (with and without Valsalva strain), a procedure that is far less sensitive than TEE due to the echocardiography imaging limitations seen in many adults. Finally, transcranial Doppler (TCD) with injection of agitated saline (with and without Valsalva strain) is a newer entrant into this arena that does not require sedation or any invasive instrumentation. The Cardiox Model 100 FDS utilizes an optical sensor positioned on the surface of the subject's skin at the scaphoid fossa of the ear. Next, a predetermined dose of an indicator dye, indocyanine green (ICG), is injected at a predetermined rate into a peripheral antecubital vein of the subject while the subject performs a breathing maneuver called a Valsalva maneuver. The exhalation by the subject into a mouthpiece connected to a pressure transducer via a flexible tubing extension, or its equivalent (ie, performing the Valsalva maneuver), is an essential step for all existing RLS detection methods. The Valsalva maneuver by the subject creates a pressure differential between the right and left sides of the heart. This Valsalva maneuver results in blood flow from the right side of the heart to the left side of the heart through an ASD, and/or causes a PFO, if present, to open, also allowing blood to flow directly from the right side to the left side of the heart without passing through the lungs (pulmonary vasculature) for oxygenation. The Earpads, including their fluorescence sensor arrays (FSA), are used to measure the relative concentration (ie, fluorescence signal level) of ICG dye in the bloodstream as a function of time. If a premature inflection or peak occurs in the ICG dye concentration level at a time point prior to the rise and fall of the concentration associated with the main bolus of indicator, then a RLS is present in the heart. The amplitude of this premature ICG dye-dilution curve (referred to as "RLS-indicator dilution curve") is used to subsequently quantify the magnitude of the right-to-left shunt by ratiometrically comparing the amplitude of this RLS indicator dilution curve to the amplitude of the main indicator dilution curve associated with that portion of the injected ICG dye that follows the normal pathway from the right side of the heart, through the lungs, and into the left side of the heart (referred to as "normal indicator dilution curve").
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.
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)