A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD)...
Ventricular Septal DefectThe purpose of this clinical trial is to verify the safety and effectiveness of the Fully Absorbable VSD Occlusion System and VSD Occlusion System produced by Shanghai shape memory alloy materials co., LTD. Clinical trials are designed as prospective, multicenter, randomized controlled, noninferiority clinical trials. Prospective randomized multicenter trial involving about 108 subjects will be enrolled in 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The success rate of occlusion at 6 months after operation is the main evaluation index in this clinical trial.
Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect
Perimembranous Ventricular Septal DefectThe purpose of this study is to evaluate the efficacy and safety of minimally invasive transthoracic device closure of ventricular septal defect. This is a multi-center randomized controlled trial. Because of the characteristics of this surgical clinical trials, surgeons, ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care unit nurses are all need to be informed. Therefore the results of this trial need to be system evaluated through objective methods to reduce bias.
Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With Closed Ventricular Septal Defect...
Pulmonary Vascular DiseasePulmonary arterial hypertension (PAH) in patients with congenital heart disease usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt. This overload leads to elevated pulmonary artery pressure (PAP) and later to increased pulmonary vascular resistance (PVR), leading to right ventricular dysfunction, considerable morbidity and even mortality. Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated, the disease already evolved to an advanced stage and treatment is often initiated too late. Our research group standardized the technique for the detection of early pulmonary vascular disease by bicycle stress echocardiography. The investigators now aim to assess this exercise technique in a group of patients with ventricular septal defect.
Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Ventricular Septal DefectTo assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.
Cardiopulmonary Function in Adults Born With a Ventricular Septal Defect
Ventricular Septal DefectThe overall objective for this study is to evaluate the cardiopulmonary function of VSD-patients compared with healthy age- and gender-matched controls. VSD patients with a surgically corrected defect and VSD patients with a small persistent defect will be included.
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval...
Post-Infarction Ventricular Septal DefectFDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder.
Reproduction and Survival After Cardiac Defect Repair
Cardiovascular DiseasesHeart Diseases14 moreTo create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women with corrected congenital heart disease and the risk of prematurity and occurrence of congenital heart defects in offspring.
Optimal Timing for Repair of Left to Right Shunt Lesions
Ventricular Septal DefectsPersistent Common Atrioventricular CanalThe purpose of this study is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals.
Rhythm Disturbances After Ventricular Septal Defects
Heart Block After SurgeryWe would like to conduct a retrospective chart review examining the incidence of surgical heart block in children treated in the Cardiac Service Line at Children's Healthcare of Atlanta. We would like to look at the last 30 surgical heart block cases seen at Children's Healthcare of Atlanta. We will collect the following information on each patient: Patient Date of Birth Date of the surgical procedure Weight of the patient at the time of surgery Concomitant Diagnoses Need for permanent pacemaker Outcome of pacing (i.e. pacing successful) We hope to look at each data element in order to determine potential risks factors for surgical heart block. By identifying the risk factors, the investigator hopes to establish a training program regarding surgical avoidance of certain areas of the heart (if possible) and education regarding pacemaker follow-up. Each patient will be given a unique study number. The patient's name, social security number, medical record number or initials will not be used in our research database.
Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions
Atrial Septal DefectsVentricular Septal DefectsProspective, monocentric study for the evaluation of latent pulmonary arterial hypertension in patients with congenital shunt lesions lost to follow-up. Lost to follow-up is defined as latest clinical control ≥ 5 years.