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Congenital Heart Defect clinical trials

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NCT ID: NCT05698277 Recruiting - Clinical trials for Congenital Heart Defect

Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

Start date: May 1, 2023
Phase:
Study type: Observational

The goal of this international multicentre prospective observational cohort study with a nested case-control study is to test some automated fetal heart functional parameters in healthy babies compared to those affected by a congenital heart condition. The main questions it aims to answer are: - If there is a significant difference between the two populations of infants - Whether these parameters could significantly improve the predictive value of actual cardiovascular profile score to predict hydrops Participants will be offered two automated cardiac function assessments between 27+6 and 29+6 gestational weeks and between 34+6 and 36+6 weeks of gestation. Functional parameters will be compared between the two study groups and evaluated over time.

NCT ID: NCT05696912 Recruiting - Cystic Fibrosis Clinical Trials

Functional Tests to Resolve Unsolved Rare Diseases. Rares.

RID
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

Rares diseases are a heterogeneous group of conditions which need important tools for diagnosis. The use of high-throughput sequencing is able to diagnose half of the patients. For the other part it is impossible to conclude due to the presence of variants of unknown significance (VOUS). Functional analysis are needed to bring strong argument to reclassify variants as pathogenic or benign. The main objective is to evaluate the diagnosis yield of this strategy.

NCT ID: NCT04737135 Recruiting - Clinical trials for Congenital Heart Disease

Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)

FIFA
Start date: July 9, 2018
Phase:
Study type: Observational [Patient Registry]

This study aims to study the correlation between biomarkers of myocardial fibrosis (extracellular volume fraction calculated by cardiac magnetic resonance imaging (MRI) (T1-mapping) and levels of molecular biomarkers of fibrosis) and adverse events in a population of patients with repaired tetralogy of Fallot.

NCT ID: NCT04619745 Recruiting - Clinical trials for Congenital Heart Defect

A Feasibility Study of Physical Activity After Surgical or Catheterization Intervention

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

This feasibility study will assess whether a 6-month, home-based, parent-led physical activity program, completed after surgical or catheterization treatment, enables young children with congenital heart defects (CHD) to achieve the recommended 180 minutes of daily physical activity. This study includes comprehensive measures of motor skill and physical activity, intervening at a very young age, and targeting the high risk status for sedentary lifestyles of children with CHD. This study will provide essential data on patient recruitment, data collection procedures, the proposed physical activity intervention and resources required to enable the design of a randomized controlled trial (RCT) to evaluate play-based, parent-delivered interventions optimized to support age-appropriate physical activity and motor skills among young children with CHD.

NCT ID: NCT04437069 Recruiting - Clinical trials for Congenital Heart Disease

Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

This study is a randomized clinical trial where participants (parents of a fetus or neonate diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that includes a values clarification exercise. Because of the novel use of decision aids in CHD in an acute setting, we will also compare participants receiving the DA in a randomized control trial to a prospective observational population of families faced with similar decisions without a DA (control group). We have designated the Brief Symptom Inventory Global Severity Index of Global Distress 3 months post-birth or death/termination as our primary outcome measure.

NCT ID: NCT04106479 Recruiting - Tetralogy of Fallot Clinical Trials

NIRS in Congenital Heart Defects - Correlation With Echocardiography

Start date: October 11, 2019
Phase:
Study type: Observational

Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow. Near infrared spectroscopy has been used in neonatal intensive care units (NICU) to measure end-organ perfusion. The investigator plan on monitoring newborns with CHD admitted to the NICU with NIRS and echocardiography during the first week of life and correlate measures of perfusion from Dopplers to cerebral and renal NIRS.

NCT ID: NCT03512613 Recruiting - Clinical trials for Congenital Heart Defect

A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects

Start date: May 29, 2018
Phase:
Study type: Observational

Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain malformations. Previous studies of cerebral MRI in infants with congenital heart defects showed that in 20-40% of cases there was preoperative brain injury and post operative with the same incidence. These findings are strongly associated with early and long-term neurodevelopmental injury. There is a necessity for a non invasive device who will monitor the cerebral blood flow during the hospitalization prior and post the cardiac defect repair surgery. The previous modal of the study device has been cleared for marketing by the FDA (k150268). The main goal of this study is to demonstrate that the new design of Ornim's c-FLOW 3310-P is easy to operate and effective in monitoring changes in cerebral blood flow in neonates as demonstrated in adults.

NCT ID: NCT03297658 Recruiting - Clinical trials for Congenital Heart Defect

Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.

Start date: November 15, 2017
Phase: N/A
Study type: Interventional

This is a single site, randomized, blinded, sham controlled, parallel group study to identify whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects (CHD).

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: NCT02258724 Recruiting - Clinical trials for Congenital Heart Disease

Swiss National Registry of Grown up Congenital Heart Disease Patients

GUCH
Start date: September 2013
Phase:
Study type: Observational [Patient Registry]

Due to successes in the last decades in pediatric heart surgery and cardiology, 90-95% of the children with congenital heart disease reach adult age.This results in an increasing number of adults or "grown-ups" with congenital heart disease (ACHD or GUCH patients) that require special health care organization and training programmes. Long term complications of these GUCH patients and optimum treatment strategies are still poorly known. The aim of this registry is to collect quantitative and qualitative data regarding GUCH patients treated in specialised centres in Switzerland.