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Tetralogy of Fallot clinical trials

View clinical trials related to Tetralogy of Fallot.

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NCT ID: NCT06282926 Not yet recruiting - Tetralogy of Fallot Clinical Trials

Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD

Start date: March 2024
Phase:
Study type: Observational

The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair. As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS). Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS. The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase.

NCT ID: NCT06097377 Completed - Tetralogy of Fallot Clinical Trials

Lymphatic Magnetic Resonance Imaging Abnormalities in Children With Tetralogy of Fallot: A Case-Control Study

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

This study examines subclinical lymphatic abnormalities in Tetralogy of Fallot patients, utilizing lymphatic magnetic resonance and near-infrared fluorescence imaging.

NCT ID: NCT06081855 Not yet recruiting - Clinical trials for Congenital Heart Disease

Predictors of Aortic Root Dilatation in Tetralogy of Fallot Patients

Start date: January 1, 2024
Phase:
Study type: Observational

- To predict vulnerable patients for aortic root dilatation in TOF patients using CT as a reliable imaging modality, thus aiding early intervention, and identifying those who will require strict follow-up. - To assess the prevalence of TOF patients who developed aortic root dilatation, and those who were complicated with dissection, AR, and aneurysm, through collecting data from a large center (Aswan Heart Centre). - To investigate the relationship between age at repair and the diameter of aortic root.

NCT ID: NCT05976204 Completed - Clinical trials for Congenital Heart Disease

Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome

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

Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair. Various studies have recently shown inflammatory biomarkers to predict morbidity and mortality in hypoxemic patients, but they are not readily available and expensive.This study aims to compare the prognostic value of neutrophil-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and thrombocyte-lymphocyte ratio (TLR) in predicting ToF primary repair outcomes. This was a retrospective observational study on ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. Preoperative NLR, ALC, and TLR were derived from blood test obtained <14 days before surgery. The primary endpoints were redo surgery, 30-day mortality, and complications. The secondary endpoints were hospital length of stay (HLOS) and postoperative LOS.

NCT ID: NCT05916976 Not yet recruiting - Clinical trials for Congenital Heart Disease

Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment

rTOF-MR-SHARP
Start date: October 15, 2023
Phase: N/A
Study type: Interventional

Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population. A new score will be used to summarize the multitude of MRI-based parameters into a single number. Individual modificators are assigned to the components of the score. The value of each modificatory will be determined as a result of this feasibility trial. This new compound score is designed to anticipate any deterioration of cardiac function, arrhythmias or sudden cardiac death. This feasibility study is the first step to establish this score and find initial values for the modifies that are assigned to the more than 40 biomarkers from MRI, clinical examinations and serum parameters that are included in this new score.

NCT ID: NCT05809310 Recruiting - Clinical trials for Congenital Heart Disease

Effects Branch PA Stenting d-TGA, ToF and TA

Start date: April 18, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The main question[s] it aims to answer are: The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions. Participants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions. Researchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)

NCT ID: NCT05691764 Completed - Cardiac Surgery Clinical Trials

Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery

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

The study aimed to evaluate the combined effects of cyclosporine and remote ischemic preconditioning on MDA, calcium cytosol concentration, and mitochondrial edema in tetralogy Fallot patients undergoing corrective surgery.

NCT ID: NCT05579964 Completed - Clinical trials for Cardiopulmonary Bypass

The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot

Start date: October 10, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Congenital heart disease (CHD) is the most common congenital abnormality found in newborns with Tetralogy of Fallot (TOF) being the most common cyanotic CHD. Total correction of TOF was performed using a cardiopulmonary bypass (CPB) machine. However, the use of CPB has a negative effect that causes inflammation and myocardial injury. Myocardial protection in patients undergoing total correction of TOF surgery is more difficult than other cyanotic CHD due to a hypertrophic right ventricular condition. Dexmedetomidine (DEX) is a selective α-2 adrenergic, which has major effects including hypnosis, sedation, and analgesia as well as cardiovascular effects. The sedation is induced by stimulating the α-2 adrenergic receptor in the locus coeruleus (LC) in the pons cerebri. DEX also increases the level of GABA and Galanin and reduces endogenous norepinephrine. The lower level of endogenous norepinephrine decreases the afterload of the ventricles, increases cardiac output, and reduces myocardial injury as a result. Furthermore, the peripheral effects of DEX can reduce myocardial ischemia-reperfusion (MIR) by inhibiting NF-кB pathway activation and reducing the number of pro-inflammatory cytokines released. Thus, the administration of DEX can prevent myocardial necrosis and apoptosis, also reducing reperfusion injury when using CPB machines. Research related to the effectiveness of administering DEX as a myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery in Indonesia is less reported. The aim of this study is to determine the effectiveness of DEX as myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery.

NCT ID: NCT05485545 Not yet recruiting - Tetralogy of Fallot Clinical Trials

Asynchrony in Operated Tetralogy of Fallot

FALLOT-XI
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.

NCT ID: NCT05452720 Recruiting - Clinical trials for Transposition of Great Vessels

MASA Valve Early Feasibility Study

MVEFS
Start date: May 18, 2023
Phase: N/A
Study type: Interventional

The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and/or regulatory clearance submission.