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Heart Defects, Congenital clinical trials

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NCT ID: NCT05330338 Recruiting - Clinical trials for Heart Defects, Congenital

Genetics of Ventriculo-arterial Discordance

PreciPed
Start date: September 7, 2022
Phase: N/A
Study type: Interventional

Number of centres planned : 16 centres in France Type of study / Study design : Research Involving the Human Person category 2. Multicentric. Prospective Planning of the study : Total duration: 22 years. Recruitment period: 24 months. Follow-up time per patients : 20 years Expected number of cases : 300 index cases: 150 single index cases and 150 trio families Treatment, procedure, combination of procedures under consideration : - Blood samples for genetic analyses collected at the inclusion visit for patients and parents in case of trio families Schedule of different visits and examinations : Inclusion visit: - Collection of demographic, clinical data from the index case and parents - DNA sampling for genetic research (biocollection) of the index case or family trio - Completion of the quality of life questionnaire Annual visit with a 20 year follow-up: - Retrieval of data from the index case - Completion of the quality of life questionnaire

NCT ID: NCT05268094 Recruiting - Clinical trials for Congenital Heart Disease in Children

Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)

COMPASS
Start date: June 2, 2022
Phase: N/A
Study type: Interventional

COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.

NCT ID: NCT05264181 Recruiting - Clinical trials for Congenital Heart Disease

Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve

EUROPULMS3
Start date: September 1, 2021
Phase:
Study type: Observational

Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right ventricular outflow tract dysfunction in patients with congenital heart diseases. Long-term outcomes following this procedure using the new generation SAPIEN 3 valve is little known. Purpose This study aims to report mid-term outcomes in a large cohort of patients who had TPVI using the SAPIEN 3 valve. Methods We designed a retrospective multicentre observational registry of patients undergoing TPVI with the SAPIEN 3 valve across centres in Europe, Middle-east and Canada. Patient-related, procedural, and mid-term outcomes data will be characterized.

NCT ID: NCT05263843 Recruiting - Heart Failure Clinical Trials

Gender Difference in NET Activation in Patients With Congenital Heart Disease and Heart Failure

FIBRONETx
Start date: February 22, 2022
Phase:
Study type: Observational

Neutrophil hyperactivation has detrimental effects on cardiac tissue after injuries, leading to fibrosis lesions and cardiac dysfunction. It is now well-established that women present with different clinical symptoms in cardiovascular disease compared to men. A cardioprotective effect in women has been suggested in some studies including patients with congenital heart disease (CHD) and heart failure. Our hypothesis is that estrogen protects the hearts of female patients aged 18-45 with CHD. There is no information available as to the involvement of neutrophils in heart failure in females compared to male patients, and therefore this study will provide important information for both the CHD and neutrophil biology fields comparing NET activation in women and men with severe CHD.

NCT ID: NCT05262907 Recruiting - Clinical trials for Congenital Heart Disease

Ventripoint Single Ventricle Study

Start date: July 8, 2022
Phase: N/A
Study type: Interventional

This study will validate a coordinate-based 3-dimensional echocardiographic technique for the assessment of cardiac size and function in children and young adults with functional single ventricles.

NCT ID: NCT05260931 Recruiting - Clinical trials for Gestational Diabetes

Fetal Cardiac Remodeling in Gestational Diabetic Pregnancies at the Moment of Diagnosis

Start date: May 1, 2021
Phase:
Study type: Observational

The aim of the present study will be to evaluate whether fetal cardiac remodeling is already present at the moment of the diagnosis of gestational diabetes (GD) in comparison with fetuses of healthy pregnant women.

NCT ID: NCT05258981 Recruiting - Clinical trials for Congenital Heart Disease

The Relationship Between Brain MRI Phenotypes, Genes and Cognitive Outcome in CHD Adults

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The main purpose of this proposal is to perform novel MRI analyses to determine the brain organizational changes associated with altered executive function and the modulating role of variants in neuroresilience and hypoxia response genes in adults with d-transposition of the great arteries (d-TGA).

NCT ID: NCT05253209 Recruiting - Clinical trials for Ventricular Septal Defect

A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects

Start date: June 29, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.

NCT ID: NCT05241418 Recruiting - Clinical trials for Congenital Heart Disease

Atrial Late Gadolinium Enhancement in Patients With Repaired Congenital Heart Disease

Start date: March 23, 2022
Phase:
Study type: Observational

In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysiology laboratory is not known. This study works to answer these questions. Participants will undergo a cardiac MRI as part of the routine clinical care that was ordered by their doctors and additional imaging by cardiac MRI will be performed.

NCT ID: NCT05213598 Recruiting - Clinical trials for Congenital Heart Disease

Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment

Start date: September 7, 2022
Phase:
Study type: Observational

Background: In Fontan Associated Liver Disease (FALD), congestion of blood in the liver causes cirrhosis. This condition can cause death. Researchers want to understand what triggers this process and find new treatments for it. Objective: To understand how long-term congestion of blood in the liver causes liver scarring that eventually leads to cirrhosis. Eligibility: People aged 18 and older who are at risk of developing FALD from the Fontan procedure. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Liver ultrasound. This uses sound waves to take pictures of the body. Participants will have an outpatient visit within 12 weeks after screening. Within 24 weeks later, they will have a 3-day hospital stay. About 2 weeks later, they will have a follow-up visit. Visits will include repeats of the screening tests and: Heart tests Stool collection Questionnaires MRI of the liver. Participants will lie on a bed that slides in and out of the scanner. They will receive a contrast agent injected into a vein. While in the scanner, they will also have an MRCP to view the bile ducts and the pancreatic duct. Fibroscan exam. This is an ultrasound that uses a special probe to look at the toughness of the liver. Upper endoscopy. This uses a thin scope to look inside the upper digestive tract. Liver biopsy. This will be taken through large vein in the neck or through the chest. Just before the biopsy, participants will have pressure measurements inside their liver. For this, a catheter will be inserted into a neck vein and guided into the liver.