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Heart Diseases clinical trials

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NCT ID: NCT05118152 Completed - Clinical trials for Congenital Heart Disease

Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle

VU3D
Start date: June 1, 2021
Phase:
Study type: Observational

Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex. As a result of the improved patient care over the last decades, the number of children and adults with single ventricle is increasing significantly. Today, the main challenge is to ensure an optimal follow-up of these new patients in order to improve their life expenctancy as well as their quality of life (QoL). Currently, echocardiography and cardiopulmonary exercice test (CPET) are central in management of patients with single ventricle as part of good clinical practice guidelines. Single ventricle volumes and function are very difficult to asses with conventional echocardiography because of their complex geometry. Indeed, single ventricle size and morphology vary depending on the patient characteristics and on the initial CHD (before surgical repair). That's why conventional 2D echocardiographic parameters are not reliable for single ventricle assessment. Magnetic resonance imaging (MRI) is more effective in assessing single ventricle volumes and function. Nevertheless, MRI is not universally available, is not practical in many situations, is expensive, and is a relative contraindication in patients with pacemakers. Over the past decade, the use of the 3D echocardiography has increased. This is an available tool that can assess ventricular function and volumes in few seconds. Recent studies shown a good correlation between 3D echocardiography and MRI for assessment of ventricular volumes and function in patient with CHD and especially in those with single ventricle. Moreover, according to some authors, CPET parameters are strongly correlated with risk of hospitalization, risk of death, physical activity and quality of life, especially in patients with single ventricle. To date, there is no study performed about the relationship between 3D echocardiography and CPET parameters in patients with single ventricle.

NCT ID: NCT05105880 Completed - Clinical trials for Congenital Heart Disease

Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease

Start date: January 1, 2018
Phase:
Study type: Observational

The investigators conducted this retrospective study in a large single center with an annual birth of more than 20,000 newborns, from January 1, 2018 to December 31, 2019, to confirm the applicability and accuracy of pulse oximetry (POX) combined cardio-auscultation to screen congenital heart disease for neonates.

NCT ID: NCT05104307 Completed - Heart Diseases Clinical Trials

Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study

Start date: November 9, 2021
Phase:
Study type: Observational

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

NCT ID: NCT05090748 Completed - Cardiac Disease Clinical Trials

Study for the Assessment of the Quality of Echocardiographic Clips.

Start date: May 15, 2022
Phase:
Study type: Observational

This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. The study will include healthcare professionals, not specialized in echocardiography, who will perform echocardiography by using UltraSight AI Guidance software, on subjects in the medical centers cardiac units.

NCT ID: NCT05088291 Completed - Clinical trials for Coronary Heart Disease

Application of a New X-ray Protective Device in Coronary Interventional Therapy

Start date: September 30, 2021
Phase:
Study type: Observational

This is a multi-center, prospective and controlled clinical trial which will enroll 200 coronary arteriography or percutaneous coronary intervention with 2-4 interventional cardiologist. The interventional cardiologist performed 100 interventional procedures using either a new protective device (NPD) or a traditional lead clothing (TLC). The cumulative dose outside the NPD or TLC and the first operator at each height (110cm, 90cm, 50cm, 10cm) was measured. The main indicators of the study are the average X-ray shielding efficiency of the NPD and the TLC at four different heights. The investigators will record all operation information in this study.

NCT ID: NCT05071092 Completed - Clinical trials for Cardiovascular Diseases

Dietary Intervention to Improve Health of Cardiovascular Patients

Start date: May 28, 2021
Phase: N/A
Study type: Interventional

Voed je Beter is a randomized, multicenter, controlled trial to examine whether personalized guidance to increase adherence to the Dutch dietary guidelines, compared to usual care, improves health of cardiovascular patients who receive regular medical treatment.

NCT ID: NCT05070819 Completed - Cardiac Disease Clinical Trials

Atrial Natriuretic Peptide in Assessing Fluid Status

Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Biomarkers can play a significant role in fluid status assessment intraoperatively.

NCT ID: NCT05067803 Completed - Cardiac Disease Clinical Trials

Study for the Assessment of USEG Software.

Start date: December 24, 2021
Phase:
Study type: Observational

The product is comprised of software that aids in automated guided ultrasound image acquisition for novice users (medical professional without experience in performing echocardiography, e.g. nurses, physicians assistants, medical doctors, medical student etc.). The software provides real-time feedback during image acquisition to optimize image capture and determine whether image quality is sufficient for medical evaluation. The software is designed to be used with any echocardiographic ultrasound system. The Philips Lumify hand-held ultrasound device will be used for this study. - Images can be acquired manually by a novice user. - Each novice user will have a training course of 8 hours, before the study commences.

NCT ID: NCT05059925 Completed - Cardiac Disease Clinical Trials

Structured Gym Activities and Aerobic Activities in People With Cardiac Conditions

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

To compare the effect of structured gym activities and traditional aerobic activities on cardiorespiratory endurance in people with cardiac conditions To compare the effect of structured gym activities and traditional aerobic activities on quality of life in people with cardiac conditions

NCT ID: NCT05049590 Completed - Acute Kidney Injury Clinical Trials

Acute Normovolemic Hemodilution in Complex Cardiac Surgery

ANH
Start date: February 28, 2022
Phase: Phase 3
Study type: Interventional

Postoperative bleeding in cardiac surgery is a frequent complication, and cardiac surgery utilizes 15-20% of the national blood supply. Packed red blood cells (pRBCs) are associated with worse short and long term outcomes. For each unit transfused, there is an additive risk of mortality (death) and cardiac adverse events. Despite current guidelines and numerous approaches to bleeding reduction, >50% of the patients undergoing cardiac surgery receive transfusions. Acute normovolemic hemodilution (ANH), a blood conservation technique that removes whole blood from a patient immediately prior to surgery, could be a valuable method to reduce transfusion in complex cardiac surgery. At the University of California, Los Angeles (UCLA), ANH is routinely utilized in patients who refuse allogenic blood transfusions such as Jehovah's Witnesses. ANH has been shown to be safe with minimal risk to patients. ANH has been studied in simple cardiac surgery, such as coronary artery bypass grafting, however it has not been studied in complex cardiac surgery, such as aortic surgery and adult congenital heart disease. ANH has been demonstrated to reduce pRBC transfusion in lower risk cardiac surgery without any significant complications. Complex heart surgery utilizes more blood products. This study could identify the benefits of ANH in a higher risk surgical group.