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Tetralogy of Fallot clinical trials

View clinical trials related to Tetralogy of Fallot.

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NCT ID: NCT04581668 Recruiting - Clinical trials for Heart Defects, Congenital

Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

Positive intra-thoracic pressures induced by mechanical ventilation can negatively impact right heart hemodynamics by restricting systemic venous return and increasing right ventricular afterload. These consequences may be detrimental in patients with a restrictive right ventricular physiology and in patients with single ventricle physiology. NAVA (Neurally Adjusted Ventilatory Assist) ventilation decreases intra thoracic pressures compared to conventional ventilation modes. Brain perfusion is both a hemodynamic indicator and a prognostic factor in cardiac postoperative care. Diffuse Correlation Spectroscopy (DCS) coupled with Near Infrared Spectroscopy (NIRS) is a new technology that allows monitoring, in addition to brain tissue oxygenation, changes in brain blood flow. This physiological study aims to evaluate the impact of NAVA mode ventilation on cerebral and systemic hemodynamics in post-operative cardiac surgery patients with preload dependant right ventricle or with passive venous return to the lungs . This prospective cross-over study will include 30 patients. Once stabilized in intensive care, patients will undergo 2 periods of ventilation in NAVA mode and conventional mode separated by a 30-minute washout period, in a random order. For each period the following information will be collected: changes in cerebral blood flow and cerebral oxygenation, hemodynamic parameters including cardiac output and oxygen transport and ventilatory parameters.

NCT ID: NCT04452188 Active, not recruiting - Clinical trials for Cardiopulmonary Bypass

Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period

T-NOX
Start date: January 18, 2021
Phase: N/A
Study type: Interventional

This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. In addition to having the various doses of oxygen, patients that participate will also have blood samples, ultrasounds of the head, and brain wave patterns monitored. The hypotheses of this trial are: - that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group - there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups. - the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery

NCT ID: NCT04359940 Recruiting - Tetralogy of Fallot Clinical Trials

Effect of Contouring Techniques on CMR Assessment of the Right Ventricle in Repaired Tetraology of Fallot

Start date: January 1, 2013
Phase:
Study type: Observational

Patients with repaired tetralogy of Fallot (RTOF) develop chronic pulmonary regurgitation and require monitoring for right ventricular dilatation. Pulmonary valve replacement can prevent irreversible right ventricular (RV) dilatation and dysfunction and cardiac magnetic resonance (CMR) is used to facilitate its optimal timing. The investigators sought to determine whether the choice of myocardial contouring technique affects preoperative RV volumetric thresholds for intervention.

NCT ID: NCT04288596 Not yet recruiting - Clinical trials for Patent Foramen Ovale

Canadian Adult Congenital Heart Disease Intervention Registry

C-ACHDiR
Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.

NCT ID: NCT04208893 Suspended - Clinical trials for Cardiovascular Diseases

Exercise Training Strategies for Children With Repaired Tetralogy of Fallot

Start date: August 20, 2019
Phase: N/A
Study type: Interventional

The investigators will explore the feasibility and safety of two exercise interventions delivered both in the hospital and in participants' homes. Preteens and adolescents who have had repaired Tetralogy of Fallot (TOF), will be grouped by age and randomly assigned to either an aerobic or strength training exercise program supervised for 12 weeks. An exploratory aim of this study will be to examine changes in fitness level, muscle strength, muscle oxygen extraction and quality of life after the intervention, and compare these measures between groups. At the end of the study, participants and parents will be interviewed to assess their satisfaction and ideas for improvements in the program.

NCT ID: NCT04205461 Recruiting - Clinical trials for Congenital Heart Disease

Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot

Start date: January 1, 2020
Phase:
Study type: Observational

Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing. Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch. While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis. At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking. The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.

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: NCT04084132 Recruiting - Tetralogy of Fallot Clinical Trials

Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year. Corrective surgery is usually performed within the first year. In 50 % of patients, enlargement with a patch is necessary to achieve relief of the outflow tract obstruction. This however results in severe pulmonary regurgitation, which eventually leads to volume overload, right ventricular dysfunction and arrhythmia. To avoid these late complications, pulmonary valve replacement with a prosthesis if performed when patients meet the current guideline criteria. Most patients meet the guideline criteria for revalving when they are between 20 and 30 years of age. The current guidelines however, are based solely on retrospective studies and novel research reveals that in more than 50 % of patients who are treated according to current practice, right ventricular volumes and function as well as exercise capacity and burden of arrhythmia do not normalize or improve. 500 patients with ToF will be enrolled in a multicentre, cross-sectional study, which will yield information about the long-term outcomes after initial repair of ToF, as well as suggestions about the optimal timing for re-valving. Among patients included in the cross-sectional study, 120 patients with free pulmonary regurgitation, will be randomized evenly for early or later re-valving with at least 10-years of follow-up, for evaluation of long-term efficacy and safety of early re-valving.

NCT ID: NCT04017975 Active, not recruiting - Clinical trials for Ventricular Septal Defect

Optical Tissue Identification for Myocardial Architecture

OPTIMA
Start date: December 20, 2019
Phase: Phase 2
Study type: Interventional

The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.

NCT ID: NCT03983512 Active, not recruiting - Heart Diseases Clinical Trials

PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Start date: October 7, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.