View clinical trials related to Pulmonary Valve Insufficiency.
Filter by:A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
Introduction: Patients on mechanical ventilation suffer alterations in the viscoelastic characteristics of the mucus due to changes in the humidity and temperature of the inhaled air and in the respiratory volumes and flows. The literature has pointed out the use of mechanical ventilators as a tool for mobilizing secretions and closed-system aspiration associated with expiratory pause has been shown to be effective in mobilizing secretions. Objectives: To assess whether there is a difference in the mass of aspirated secretion with the application of the expiratory pause during aspiration. Methods: A crossover, randomized study. Applied to children aged 0 to 5 years and 11 months who are intubated for 24 hours with orotracheal tubes or tracheostomy. There will be an exclusion of patients who present with undrained pneumothorax, cranial hypertension or any other clinical situation that has a clinical contraindication to aspiration and patients whose parents do not agree to participate in the study. The technique will be during aspiration in the tube with where to apply or not the expiratory pause on the mechanical ventilator. This secretion will be weighed so that there is fidelity in the results.
The pathophysiology of SARS-COV-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ARDS). In this case, very few studies have investigated changes in gas exchange during COVID-19 progression in spontaneously breathing patients. The investigators purpose in this study to explore the pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to COVID-19. Moreover, our aim is to identify early markers associated with worsening respiratory failure and requiring endotracheal intubation.
Database study of the adherence to treatment to non-invasive mechanical ventilation
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
Acupuncture is a treatment intervention used globally for a wide variety of disorders. Its efficacy has been established over the course of 3000 years, originating in Asia and diversifying worldwide.The scientific basis for acupuncture remains unclear. Nonetheless, acupuncture releases neurochemical substrates, such as endorphins, serotonin, and norepinephrine.Acupuncture is considered to be a safe treatment when applied by a certified acupuncturist.Acupuncture has already been deployed in the treatment of sepsis or muscle weakness.Studies have revealed that acupuncture significantly improved grip strength and respiratory muscle strength in chronic obstructive pulmonary disease participates.Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.The investigators designed a study to compare the effects of acupuncture, electroacupuncture, and neuromuscular electrical stimulation on mechanical ventilation patients with weaning difficulties
Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility. Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.
The objective of the clinical investigation presented is to guarantee the safety and usability of the RESPIRA ADVANCED medical device in patients undergoing mechanical ventilation in the ICU, both stable patients and in the weaning phase. Through the clinical investigation, the reliability and durability of the device, the adequacy of the ventilatory parameters and their consistency over time, and the response of the patients wills be checked. During the entire course of the patient's participation in the study, the patient will be closely monitored following the protocol specifications, to guarantee safety and evaluate the effectiveness of the device.
This study investigates damage of the right cardiac chamber in adult patients with a congenital heart defect involving the pulmonary valve (the heart valve between the right cardiac chamber and the lungs). The investigators want to investigate if novel, less invasive techniques are feasible to assess damage of this right cardiac chamber, to improve follow-up and timing of intervention (valve replacement) in this group of patients.