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Transposition of Great Vessels clinical trials

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NCT ID: NCT06258083 Completed - Clinical trials for Transposition of the Great Arteries

Systemic Right Ventricle Long-term Outcome

SINCERE
Start date: August 26, 2022
Phase:
Study type: Observational

Patients with the transposition of great arteries (TGA) who undergo atrial switch operation and congenitally corrected TGA (ccTGA) patients have the right ventricle as their systemic ventricle. Function of the systemic right ventricle (SRV) could deteriorate which is associated with impaired prognosis. It is of paramount importance to understand the course and fate of these patients during a long-term follow-up to identify the determinants of adverse outcomes.

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: NCT05690854 Recruiting - Clinical trials for Transposition of Great Arteries

Cardiovascular Magnetic Resonance in Adults With SysTemic Right Ventricle (STAR)

STAR
Start date: November 29, 2022
Phase:
Study type: Observational

The main aim of the study is to explore HFs in SRV, comparing their magnitude and direction with that of subpulmonary RV and systemic LV. As a secondary aim, possible association or correlation will be investigated between SRV energetics and: i) patient functional parameters, e.g., the results from cardiopulmonary exercise test (CPET), ii) patient clinical status, including the occurrence of adverse outcome (a composite of death, hospitalization for heart failure, cardiovascular arrest, sustained arrhythmias).

NCT ID: NCT05524324 Not yet recruiting - Clinical trials for Congenital Heart Disease

Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT

RIGHT-CRT
Start date: September 2022
Phase: N/A
Study type: Interventional

The main objective of RIGHT-CRT is to assess the impact/efficacy of CRT on functional capacity in ACHD patients with SRV.

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.

NCT ID: NCT05160116 Completed - Clinical trials for Transposition of Great Vessels

Influence of Timing of Switch Operation in Transposition of Great Arteries

Start date: December 15, 2021
Phase:
Study type: Observational

Transposition of great vessels are usually corrected by an arterial switch operation. This operation is often done during the first week of life as surgical delays lead to deconditioned left ventricle. On the other hand early surgery carries also risks as neonatal physiology may have problems adapting to an intervention under cardiopulmonary bypass, possible pulmonary hypertension. Arterial switch operation between 2008 and 2020 done at our center will be reviewed. Primary outcome will be mortality or severe postoperative morbidity. Patients will be divided in 2 groups according to the presence or absence of the primary outcome. After propensity score matching, they will be analysed according to the timing of operation.

NCT ID: NCT05137873 Recruiting - Clinical trials for Great Vessels Transposition Surgery

Measurement of the Prevalence of Sensory Integration Disorders in Babies Having Heart Disease Surgery for Transposition of the Great Vessels Before 6 Months of Age

SENSOCOEUR
Start date: April 14, 2022
Phase:
Study type: Observational

The purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.

NCT ID: NCT05089773 Completed - Outcome, Fatal Clinical Trials

Outcomes of Transposition of the Great Arteries After Arterial Switch Operation

Start date: December 1, 2019
Phase:
Study type: Observational

Transposition of the great arteries (TGA) is a complex cyanotic congenital heart disease and patients suffer from a high mortality rate within one year of age without appropriate management. The therapeutic effect of arterial switch operation (ASO) is satisfactory with low surgery mortality of 2-5%, and thus, has become the treatment of choice for surgical correction of d-TGA. Outcomes of ASO in TGA in china are rare. This is a retrospective study reporting the outcomes of ASO in TGA.

NCT ID: NCT04788082 Withdrawn - Clinical trials for Transposition of the Great Arteries

Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images (CT or MRI), aid in procedural planning. 3D printed models for heart surgery have the potential to improve a clinician's preparedness and therefore may reduce surgically-related morbidity and mortality. This randomized clinical trial aims to evaluate whether pre-procedural planning of surgeons exposed to a patient-specific 3D printed heart model will decrease cardiopulmonary bypass time, morbidity, and mortality.

NCT ID: NCT04616222 Recruiting - Clinical trials for Transposition of Great Vessels

A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels

CELSIOR-TGV
Start date: September 1, 2020
Phase:
Study type: Observational

Celsior® is an organ preservation solution used for the harvesting and the preservation of solid organs. Its use as a crystalloid cardioplegia solution has been established recently. Its main advantage is the long duration of myocardial protection. Compared to the other cardioplegia solutions, it allows a reduced amount of solution administered during the surgery and fewer interruptions during the intervention for the administration of supplemental doses of cardioplegia for long and complex operations. The objective of this register is to compare the safety and the efficacy of Celsior® to the old cardioplegia solution Saint-Thomas used as cardioplegia solution in surgery of the transposition of great vessels, the arterial switch operation.