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Heart Defects, Congenital clinical trials

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NCT ID: NCT06406517 Not yet recruiting - Clinical trials for Congenital Heart Disease

Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics

Start date: May 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to learn how well and at what doses gadopiclenol, a new intravenous (IV) contrast agent used for MRI, works to produce high-quality MRI images of the heart, in patients with a history of congenital heart disease, when compared to gadobenate dimeglumine, the IV contrast agent that is normally used at our institution for heart (cardiac) MRI. The main questions it aims to answer are: - Does using gadopiclenol result in similar or superior image quality, similar signal-to-noise ratio (SNR), and similar flow measurements with 4-dimensional (4D) flow cardiac MRI when compared to gadobenate dimeglumine? - At what dose(s) does gadopiclenol result in similar image quality (using the above metrics) for cardiac MRI when compared to gadobenate dimeglumine? Researchers will compare cardiac MRI images obtained after administration of gadopiclenol to cardiac MRI images obtained after administration of gadobenate dimeglumine (called the standard of care treatment) to see if the images are of similar or superior quality. Participants will: - Be randomized to receive either gadopiclenol at one of three different doses or gadobenate dimeglumine before their congenital heart cardiac MRI - Undergo their congenital heart cardiac MRI as they would during the course of normal clinical care.

NCT ID: NCT06392555 Not yet recruiting - Clinical trials for Congenital Heart Disease

Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

Start date: May 2024
Phase:
Study type: Observational

Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.

NCT ID: NCT06381128 Not yet recruiting - Clinical trials for Cardiac Congenital Defects

Coronary Arteries Anomalies by CT in Children With CHD

Start date: January 1, 2025
Phase:
Study type: Observational

Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction.

NCT ID: NCT06373705 Not yet recruiting - Clinical trials for Congenital Heart Disease in Children

Cardiac Simulator for Surgical Planning

Start date: April 2026
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are: To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator. To aid surgeons in envisioning different surgical approaches for each individual patient. To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease. Participants will: Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator. Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group.

NCT ID: NCT06373627 Not yet recruiting - Clinical trials for Congenital Heart Disease

Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease

PEACE-HYPNO
Start date: May 2, 2024
Phase: N/A
Study type: Interventional

The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects.

NCT ID: NCT06371937 Not yet recruiting - Heart Failure Clinical Trials

iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease

INFERENCE
Start date: May 1, 2024
Phase:
Study type: Observational [Patient Registry]

The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease.

NCT ID: NCT06356454 Not yet recruiting - Physician's Role Clinical Trials

Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease

Start date: June 2, 2024
Phase:
Study type: Observational

Despite significant clinical benefits and recommendations of clinical practice guidelines to refer patients for exercise and physical activity counselling in the capacity of cardiac rehabilitation (CR), CR is largely underutilised and not implemented effectively. Studies have reported that the reasons for the low implementation of CR are multifactorial at the healthcare system, physician and patient levels. Therefore, the aim of this study was to investigate the knowledge, attitudes and practical applications of paediatric cardiologists regarding cardiac rehabilitation and specifically exercise and physical activity in children with congenital heart disease (CHD).

NCT ID: NCT06325280 Not yet recruiting - Clinical trials for Congenital Heart Disease

Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease

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

There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function.

NCT ID: NCT06324903 Not yet recruiting - Echocardiography Clinical Trials

Role of Echocardiography in Optimization of Cardiac Catheterization in Children With Congenital Heart Disease

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

Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals. 1. To improve diagnostic accuracy by creating a systematic approach for image acquisition and interpretation across different procedural timepoints. 2. To promote consistent hemodynamic evaluations to reliably assess cardiac function and blood flow. 3. To enable optimized procedural planning and intraprocedural guidance via comprehensive delineation of anatomy and pathophysiology. 4. To facilitate standardized longitudinal monitoring after interventions to evaluate outcomes and detect complications.

NCT ID: NCT06281639 Not yet recruiting - Clinical trials for Congenital Heart Disease

RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging

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

The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in <1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.