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Heart Diseases clinical trials

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NCT ID: NCT04152967 Recruiting - Clinical trials for Congenital Heart Disease

New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract

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

Valved conduits used for the reconstruction of right-ventricular outflow tract are applied in the surgical repair of complex congenital heart disease(CHD) such as pulmonary atresia(PA), truncus arteriosus, severe tetralogy of Fallot(TOF) for their significant roles in reducing pulmonary valve regurgitation and preserving right ventricle function. With a rising cases of complex CHD and patients with pulmonary valve regurgitation in TOF repair, a further demand is underway for valved conduits. Meanwhile, common biological valved conduits applied in foreign countries are not approved in China yet, with high failure and reintervention, reducing the long-term survival. Our team manufactured a novel valved conduit with 0.1mm expanded polytetrafluoroethylene and gore-tex conduit. This ePTFE valved conduit played a satisfying role in anti-regurgitation and failure rate through in vitro fluid test and animal experiments. Besides, our team manufactured templates for the conduit and also simplified the suturing process so that the repeatability of suturing valved had been risen. Until now, over 70 cases have been implanted with this ePTFE valved conduit with positive early and mid-term follow-up results. Despite the progress which have been made, there still remain some problems to solve. First, systematic prospective randomized comparative study will be performed. Second, this is just a single-center study. Third, these patients should have longer follow-up time to evaluate the ePTFE conduit long-term effect. Finally, imaging data are blank for evaluating the function of the conduit and right ventricle. In this prospective comparative research, the new designed ePTFE valved conduit and bovine jugular vein valved conduits are conducted as a randomized controlled trail. Cardiac magnetic resonance imaging is used to precisely evaluate the anti-regurgitation effect of the valved conduit and the right ventricle function. Investigators can further access the application of this newly designed ePTFE valved conduit. Investigators aim to provide a self-manufactured, low failure rate valved conduit.

NCT ID: NCT04152330 Completed - Clinical trials for Congenital Heart Disease

Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial

Start date: November 30, 2019
Phase: N/A
Study type: Interventional

Problem: With the increased survival rate of children with congenital heart disease, other health problems, in addition to the clinic, have emerged, such as the risks of developmental delay to which these children are exposed. There is a need for low-cost intervention studies that seek to minimize these risks. Objective: To evaluate the effect of an early stimulation program using parents as vectors of intervention, on the neurodevelopment of children with CHD Methodology: Randomized clinical trial, conducted with 44 dyads of parents-babies with CH considered as medium and high risk for developmental delays according to the guidelines of the American Heart Association (2012). The study will consist of two groups G1 (Intervention) and G2 (controls). G1 parents will receive guidance for 6 weeks of stimulation activities and will be instructed to keep an online execution diary, direct with the researcher through videos, and messages via cell phone. G2 parents will receive the standard guidelines currently used in pediatric cardiology clinics. Children from both groups will be assessed at the beginning and end of the 6 weeks by the Bayley Baby and Toddler Development Scales (3rd Edition). A questionnaire on the applicability of the protocol will be administered to the parents of the intervention group Expected results: Better neuropsychomotor performance in children after applying the early stimulation protocol. Perspectives: Create a body of information that can serve as a basis for the formulation of policies for intervention and surveillance of the development of this population.

NCT ID: NCT04151680 Recruiting - Atrial Fibrillation Clinical Trials

Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients

INTERMITTENT
Start date: December 1, 2019
Phase:
Study type: Observational [Patient Registry]

Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists. The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.

NCT ID: NCT04151160 Completed - Clinical trials for Congenital Heart Disease

Point of Care Ultrasound Measurements of Perioperative Edema in Infants With Congenital Heart Disease

Start date: January 13, 2020
Phase:
Study type: Observational

Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in babies, so it can be hard to know how much diuretic they need to treat the swelling. The investigators are looking for a better way to measure swelling in babies who have had heart surgery. Ultrasound uses sound waves to take pictures of the inside of the body. Ultrasound is used to take pictures of babies before they are born and to take pictures of their heart after they are born. New ultrasound software has been made from a company called MuscleSound that can quickly measure the amount of swelling in adults, usually in less than 2 minutes. This software has not yet been used to measure swelling in kids. This study plans to learn more about swelling in babies and will try to measure swelling in babies before and after heart surgery with the new ultrasound software. The study will also make the same measurements in babies who do not have heart disease to compare to babies having heart surgery.

NCT ID: NCT04150120 Enrolling by invitation - Clinical trials for Congenital Heart Disease

eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness

eChildHealth
Start date: October 15, 2019
Phase: N/A
Study type: Interventional

The overall aim is twofold: 1) to stretch the borderline regarding the present knowledge of clinical and economic cost-effectiveness of eHealth as an aid for facilitating and supporting self-management in families with long-term childhood illness, and 2) to develop a sustainable multidisciplinary research environment for advancing, evaluating, and implementing models of eHealth to promote self-management for children and their families. A number of clinical studies are planned for, covering different parts of paediatric healthcare. The concept of child-centred care is essential. Experienced researchers from care science, medicine, economics, technology, and social science will collaborate around common issues. Expertise on IT technology will analyse the preconditions for using IT; economic evaluations will be performed alongside clinical studies; and cultural and implementation perspectives will be used to analyse the challenges that arise from the changes in relations among children, family and professionals, which may occur as a result of the introduction of eHealth. Child health is not only important in itself. Investments in child health may also generate significant future gains, such as improved educational and labour market performance. Six complex, long-term and costly challenges in paediatric healthcare are planned for, involving eHealth technology such as interactive video consultation, pictures, on-line monitoring, and textual communication. The research follows an international framework for developing and evaluating complex interventions in healthcare. End-users (families) and relevant care providers (professionals in health and social care) will participate throughout the research process. The overall aim is certainly to analyse eHealth as an aid for facilitating and supporting self-management. However, the plan also includes the research issue whether eHealth at the same time improves the allocation of scarce health care- and societal resources.

NCT ID: NCT04148820 Not yet recruiting - Clinical trials for Ischemic Heart Disease

One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease

ONCE
Start date: November 1, 2019
Phase: Phase 4
Study type: Interventional

Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta-blockers. Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists. The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

NCT ID: NCT04142021 Recruiting - Clinical trials for Coronary Artery Disease

Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)

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

To assess the feasibility of coronary computed tomography angiography (CTA) and fractional flow reserve derived from CTA (FFRCT) to replace invasive coronary angiography (ICA) as a surgical guidance method for planning and execution of coronary artery bypass graft (CABG) in patients with 3-vessel disease with or without left main disease. The FASTTRACK CABG study is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept, and first-in-man study with feasibility and safety analysis. Surgical revascularization strategy and treatment planning will be solely based on coronary CTA and FFRCT without knowledge of the anatomy defined otherwise by ICA that will be viewed and analyzed only by the conventional heart team. Clinical follow-up visit including coronary CTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging with functional assessment and compared to ICA. Primary feasibility endpoint is CABG planning and execution solely based on coronary CTA in 114 patients. Primary safety endpoint based on 30-day coronary CTA is graft assessment either at the ostium, in the shaft or at the anastomoses of each individual graft either single or sequential. The FASTTRACK CABG study is the first study to assess safety and feasibility of planning and execution of surgical revascularization in patients with complex coronary artery disease, solely based on coronary CTA combined with FFRCT.

NCT ID: NCT04141605 Enrolling by invitation - Heart Failure Clinical Trials

Global Utilization And Registry Database for Improved heArt preservatioN

GUARDIAN
Start date: February 14, 2020
Phase:
Study type: Observational [Patient Registry]

The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.

NCT ID: NCT04140331 Terminated - Heart Diseases Clinical Trials

Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery

ACTI-CARD
Start date: January 9, 2020
Phase:
Study type: Observational

Short term morbidity after elective cardiac surgery remains significant. Standard predictive models, considering simple patient demographics and clinical parameters, show limited efficiency in individual operative risk assessment. There is growing evidence about daily physical activity as a relevant indicator of preoperative "frailty". Although cardiopulmonary exercise testing remains a gold standard, we are looking for more simple tools in order to identify patients with poor physical condition. Accelerometry may be an objective and reproductible method to measure physical activity at patient's home.

NCT ID: NCT04138966 Recruiting - Anesthesia Clinical Trials

Comparing Skin Conductance and Nol-index

Start date: October 20, 2019
Phase:
Study type: Observational

Comparison of twà different nociception monitors during general anesthesia