Below are current clinical trials.4 studies in Congenital heart defects in children
(open studies only).
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This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn surgical procedure. The investigators are doing this research study to find out if autologous stem cells from the individual's own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment for the management of HLHS.
The primary aim of this study is to create a streamlined home monitoring process with modern technologies that are both usable and efficient. The overall objective of this study is to determine whether or not this application helps improve the efficiency of medical care teams while providing care to interstage participants through the use of usability metrics. Secondarily, this study introduces a prioritization system that estimates the current risk profile of individual patients to help medical care teams better prioritize their weekly workflows. Although this mobile application is not a mobile medical device according to the definition of the FDA guidance documents (not requiring IDE), documenting the feasibility of this mobile application to be used within the context of standardized home monitoring programs will inform the use of this technology into clinical practice.
The purpose of this study is to validate novel echocardiographic parameters and algorithms to quantitatively evaluate right ventricular function in patients with Hypoplastic Left Heart Syndrome (HLHS) by applying these methods to previously acquired echocardiographic examinations.
Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that consists of multiple obstructions to flow through the left heart and aorta, as well as hypoplasia of the left ventricle. Most patients require a three-stage surgical protocol starting within days of birth. Stage I of this process is the Norwood reconstruction (within the first few days of life), Stage II (usually required within 3-8 months) involves creation of a direct connection between the patient's superior vena cava and the pulmonary arterial confluence (bidirectional Glenn anastomosis), and the last stage is creation of a Fontan circulation (typically within the first 2-4 years). This "single ventricle" approach requires the right ventricle to perform as the only circulatory pump for the entire body.
Our long-term goal is to develop regenerative strategies to strengthen and augment the right ventricular muscle of the single-ventricle heart following surgical palliation in HLHS patients. To determine the safety and feasibility of a cell-based therapeutic intervention at the Stage II surgery, we aim to document the natural history of post-surgical care in HLHS patients having undergone standard of care with protocol specific follow-up over the course of a 6-month period.
This prospective study will document the natural history in patients with HLHS after planned Stage II surgical palliation with a focus on cardiovascular parameters within 6 months following surgery in 10-20 patients.
June 17, 2017
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- Congenital heart defects. National Heart, Lung, and Blood Institute. https://www.nhlbi.nih.gov/health/health-topics/topics/chd. Accessed Feb. 8, 2017.
- Bonow RO, et al. Diseases of the heart, pericardium, and pulmonary vasculature bed. In: Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine. 10th ed. Philadelphia, Pa.: Saunders Elsevier; 2015. http://www.clinicalkey.com. Accessed Feb. 8, 2017.
- Overview of congenital cardiovascular anomalies. Merck Manual Professional Version. http://www.merckmanuals.com/professional/pediatrics/congenital-cardiovascular-anomalies/overview-of-congenital-cardiovascular-anomalies. Accessed Feb. 8, 2017.
- About congenital heart defects. American Heart Association. http://www.heart.org/HEARTORG/Conditions/CongenitalHeartDefects/AboutCongenitalHeartDefects/About-Congenital-Heart-Defects_UCM_001217_Article.jsp#.WKIlDVUrJ0w. Accessed Feb. 8, 2017.
- Facts about hypoplastic left heart syndrome. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/heartdefects/HLHS.html. Accessed Feb. 8, 2017.
- Congenital heart disease. National Health Service. http://www.nhs.uk/Conditions/Congenital-heart-disease/Pages/Introduction.aspx. Accessed Feb. 8, 2017.
- Gil-Jaurena JM, et al. 15 years of minimally invasive paediatric cardiac surgery; development and trends. Anales de Pediatria. 2016;84:304.
- Riggin EA. Allscripts EPSi. Mayo Clinic, Rochester, Minn. March 7, 2017.
- Taggart NW (expert opinion). Mayo Clinic, Rochester, Minn. Feb. 14, 2017.
- Atorvastatin. Micromedex 2.0 Healthcare Series. http://www.micromedexsolutions.com. Accessed Feb. 24, 2017.
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Congenital heart defects in children