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Heart Defects, Congenital clinical trials

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NCT ID: NCT02909543 Recruiting - Clinical trials for Women With Congenital Heart Diseases

The Life Experience of Young Women (Age 18-38) Who Live With Congenital Heart Disease

Start date: September 2016
Phase: N/A
Study type: Observational

This research will focus on young women between the ages of 18-38 who underwent a heart operation and their life experiences. This research will focus on these life events and the paradigm of these women being raised as "heart sick," and consequently lacking self-esteem (Frigiola, Bull, & Wray, 2014; Hickey et al., 2012). Most qualitative studies focusing on the quality of life compare men and women, completely ignoring women's body image and the experience of womanhood (Hickey et al., 2012; Hövels-Gürich et al., 2007; Sarikouch, et al., 2013). This study aims to focus on women's stories about their life experiences and the influence of surgery(ies) on their daily life using an the qualitative phenomenological approach.

NCT ID: NCT02897323 Recruiting - Clinical trials for Congenital Heart Disease

Northwest Adult Congenital Heart Disease Observatory

CARL
Start date: November 14, 2016
Phase: N/A
Study type: Observational

The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.

NCT ID: NCT02852031 Recruiting - Clinical trials for Hypoplastic Left Heart Syndrome (HLHS)

National Collaborative to Improve Care of Children With Complex Congenital Heart Disease

NPC-QIC
Start date: May 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.

NCT ID: NCT02825472 Recruiting - Clinical trials for Congenital Heart Disease

Exercise Training in Grown-up Congenital Heart Disease

ExTra-GUCH
Start date: February 2016
Phase: N/A
Study type: Interventional

Rationale: Regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on exercise training in adult patients with congenital heart disease. Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Study design: International, multi-centre parallel randomized controlled trial. Study population: Adult patients with congenital heart disease, who are in New York Heart Association (NYHA) class II or III. Intervention (if applicable): The intervention group receives a six-month individualized exercise training program, the control group receives usual care. Main study parameters/endpoints: The primary outcome is the change in peakVO2 between patients in the sports participation group, and the control group. Secondary outcome measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.

NCT ID: NCT02752399 Recruiting - Clinical trials for Pulmonary Hypertension

Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome

Start date: April 2016
Phase: N/A
Study type: Observational

The purpose of this study is to verify the applicability Six minutes walk test and Shuttle walk test in assessing functional capacity in patients with Eisenmenger Syndrome. Patients will undergo three functional tests, being the six-minute walk test, shuttle walk test and cardiopulmonary exercise test on a cycle ergometer, associated with evaluation of metabolic and ventilatory variables and cardiac monitoring throughout the test.

NCT ID: NCT02744677 Recruiting - Clinical trials for Pulmonary Valve Insufficiency

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Start date: July 5, 2016
Phase: N/A
Study type: Interventional

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

NCT ID: NCT02731248 Recruiting - Clinical trials for Congenital Heart Disease

Pulse Oximeter Screening in Congenital Heart Disease

POX
Start date: April 2016
Phase: N/A
Study type: Observational

Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

NCT ID: NCT02691689 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions

Start date: November 2015
Phase: N/A
Study type: Interventional

Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is associated with considerable morbidity and even mortality. Next to environmental risk factors, the investigators believe that there is an important role of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The investigators hypothesize that the genotype is partly responsible for the phenotypic variability in patients with congenital shunt lesions, where some develop PAH and others do not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening could be a useful additional tool for early detection of patients at risk of pulmonary vascular disease and PAH development, with new opportunities for prevention or early treatment.

NCT ID: NCT02658266 Recruiting - Clinical trials for Congenital Heart Defect

Effect of Resistance Training in Adults With Complex Congenital Heart Disease

Start date: February 2016
Phase: N/A
Study type: Interventional

Adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. There is only one study assessing the effects of resistance training in patients palliated with Fontan procedure. The hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.

NCT ID: NCT02622152 Recruiting - Clinical trials for Heart Defects, Congenital

Right Lateral Positioning of Postoperative Pediatric Cardiac Surgery

Start date: January 30, 2016
Phase: N/A
Study type: Interventional

Directly following cardiac surgery for congenital heart disease; patients are not receiving routine turning every two hours to prevent pressure ulcers, because a negative influence on hemodynamic parameters is assumed. Investigators have suggested that lateral position may have clinically significant effects on oxygenation in cardiac surgery patients.