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Heart Defects, Congenital clinical trials

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NCT ID: NCT02498626 Completed - Clinical trials for Heart Defects, Congenital

Mixed Venous Oxygen Saturation From Central Venous Line, Venous Side of Heart Lung Machine and the Pulmonary Artery

Start date: December 2014
Phase: Phase 2
Study type: Observational

This study was designed to examine if venous saturations from the central venous line and from the venous side of the heart lung machine are interchangeable or not with mixed venous saturation from the pulmonary artery in children undergoing open heart surgery for correction of various congenital heart defects.

NCT ID: NCT02493634 Completed - Clinical trials for Congenital Heart Defect

Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire

MRWIREPMCF
Start date: August 2015
Phase: N/A
Study type: Interventional

This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.

NCT ID: NCT02492269 Active, not recruiting - Clinical trials for Congenital Heart Disease

Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study

Start date: May 2014
Phase: Phase 2
Study type: Interventional

The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.

NCT ID: NCT02485366 Withdrawn - Clinical trials for Heart Defects, Congenital

Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Start date: June 2020
Phase: Phase 4
Study type: Interventional

Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. Stored blood undergoes some changes that may make it less effective in achieving this goal. The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to children undergoing heart surgery. Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this study is considered investigational. This is a pilot study and data will be collected for future protocol development.

NCT ID: NCT02475863 Not yet recruiting - Clinical trials for Congenital Heart Defects

Model-based Versus Traditional Warfarin Dosing in Children

WATCH
Start date: August 2015
Phase: N/A
Study type: Interventional

This study compares the clinical effectiveness of a new algorithm (model-based warfarin dosing) with standard practice (doctor's own judgement and intuition) designed to determine the most appropriate anticoagulant dose of warfarin in children after congenital heart surgery.

NCT ID: NCT02475759 Completed - Clinical trials for Congenital Heart Disease

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

NCT ID: NCT02463292 Completed - Clinical trials for Congenital Heart Disease

Quality of Life in Young Adults With Congenital Heart Disease

Start date: May 2015
Phase: N/A
Study type: Observational

This study aims to evaluate the psychosocial situation of adult congenital heart disease (CHD) patients in terms of health-related quality of life, mental health, academic achievement, and employment status. By assessing a wide variety of medical (e.g., disease severity) and psychosocial (e.g., life events, coping strategies, personality) risk factors it will be possible to better understand the variables that influence psychosocial outcome of young adults with congenital heart disease. This will further improve the understanding of the lifelong consequences of a congenital heart malformation. Factors that proof to be predictors of favorable outcome represent a resource of resilience and therefore should play an important role in the care of CHD patients. By implementing those results in patient care the investigators aim to achieve an improved psychosocial outcome among adult congenital heart disease (ACHD). Hypothesis 1: It is expected that perceived health status, health-related quality of life and psychological adjustment will not differ between the patient and the control group. However, academic achievement and employment status are expected to be poorer in young adults with congenital heart disease compared to healthy controls. Hypothesis 2: It is assumed that parental socioeconomic status, problems in emotional regulation and impaired social support will be related to a negative psychosocial outcome and health-related quality of life. Moreover, the investigators hypothesize that disease severity is associated with academic outcome and employment status.

NCT ID: NCT02462434 Completed - Clinical trials for Stress, Psychological

Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology

Start date: April 2013
Phase: N/A
Study type: Interventional

This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates born with single ventricle physiology. Half of the participants will receive early palliative care team consultation, while the other half will receive usual care (no or late palliative care intervention). The investigators hypothesize maternal stress, anxiety, and depression will be lower in the palliative care intervention group compared with the control group, and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment.

NCT ID: NCT02443662 Completed - Clinical trials for Heart Defects, Congenital

Colloid Osmotic Pressure in Patients With Fontan Circulation

Start date: September 2015
Phase:
Study type: Observational

Children born with univentricular heart will go through step surgery and end up with a Fontan circulation. A circulation with cause problems with body fluid balance.This project will evaluate changes in interstitial colloid osmotic pressure in patients 10 year after completion of a three step Fontan surgery. This project will evaluate whether increased micro vascular leakage and change in interstitial colloid osmotic pressure are present in patients after ten years with a Fontan circulation.

NCT ID: NCT02433990 Completed - Clinical trials for Congenital Heart Disease

Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease

Start date: April 2014
Phase:
Study type: Observational

This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.