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Heart Defects, Congenital clinical trials

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NCT ID: NCT00556231 Completed - Clinical trials for Congenital Heart Disease

Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise

Start date: November 2007
Phase: N/A
Study type: Observational

Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue's absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and hemoglobin without oxygen. During cardiac surgery, multi-site NIRS monitoring is used to determine the heart's output by comparing the amount of oxygen available to discrete regions of the body nourished by different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen available to the brain (cerebral), while leads placed over the kidney reflect oxygen available to the internal organs (somatic). NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying cardiac output through the patterning of somatic and cerebral oxygenation in combination with exercise stress test data has not been researched. We hypothesize that addition of multi-site NIRS monitoring to the standard data collection already achieved during exercise testing, will enable calculation of anaerobic threshold and cardiac output prediction. This will assist in determining appropriate timing for surgical intervention, predicting the post operative course and testing response to medication.

NCT ID: NCT00538785 Completed - Clinical trials for Congenital Heart Disease

A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease

Start date: October 2005
Phase: Phase 2
Study type: Interventional

The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.

NCT ID: NCT00497705 Completed - Clinical trials for Heart Defects, Congenital

Genes Causing Ebstein's Anomaly

Start date: July 3, 2007
Phase: N/A
Study type: Observational

This study will investigate Ebstein's anomaly, a congenital abnormality of the tricuspid valve of the heart and try to identify the genetic origins of the disease. Adults and children 2 years of age and older with Ebstein's anomaly and healthy volunteers may be eligible for this study. Participants undergo the following procedures: - Blood tests: Three tube of blood will be collected, with the total amount limited to about half a teaspon for each two pounds of body weight. - Saliva sample collection: A small amount of saliva is collected by spitting into a sterile container. - Oral (cheek) swab: Cells are collected from the mouth using a soft brush to swab the inside lining of the cheek. - Electrocardiogram: The electrical activity of the heart is recorded using electrodes placed on the chest. - Echocardiogram: Heart function is assessed using ultrasound.

NCT ID: NCT00486928 Completed - Clinical trials for Aortic Valve Disease

Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis

Hall-Kaster
Start date: May 2004
Phase: N/A
Study type: Observational

Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet HF in the period 1977-87. In the present study we followed all 816 patients undergoing aortic valve replacement (AVR) over a 25-year period.

NCT ID: NCT00480740 Completed - Clinical trials for Atrial Septal Defect

The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

NCT ID: NCT00465218 Completed - Clinical trials for Aortic Valve Disease

Transcranial Doppler (TCD) Assessment During Early Anti-thrombotic Therapy After Bioprosthetic Aortic Valve Replacement

Tissue-Valve
Start date: March 2007
Phase: Phase 1
Study type: Observational

The purpose of this study is to determine if there is any difference in the counts of cerebral emboli and platelet function between two prophylactic treatments of thrombosis currently used at University of Ottawa Heart Institute for the first three months after surgery in low-risk patients undergoing aortic valve replacement with a bioprosthetic valve: 1) daily use of high-dose aspirin [325 mgs], and 2) the combination of oral Warfarin [target INR 2.0 to 3.0] and low-dose aspirin [81 mg].

NCT ID: NCT00450684 Completed - Clinical trials for Congenital Heart Defects

Cardiac Resynchronization Therapy in Congenital Heart Defects

CARE-CHD
Start date: May 2007
Phase: Phase 2/Phase 3
Study type: Interventional

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).

NCT ID: NCT00446927 Completed - Clinical trials for Cardiopulmonary Bypass

SPY Imaging System: Its Role in Pediatric Cardiac Surgery

Start date: April 2007
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00446108 Completed - Clinical trials for Congenital Heart Disease

Retrospective Pulmonary Valve Replacement Imaging

Start date: February 2007
Phase: N/A
Study type: Observational

This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement. The primary interest of the study is to analyze the routine pre- and post-operative imaging studies.

NCT ID: NCT00443599 Completed - Hyperglycemia Clinical Trials

SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

SPECS
Start date: November 2006
Phase: N/A
Study type: Interventional

Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk of death. This study will examine the effectiveness of maintaining normal blood glucose levels at decreasing infections and improving recovery in young children undergoing heart surgery.