View clinical trials related to Ventricular Assist Device.
Filter by:The frailty syndrome is important to consider in perioperative cardiac assistance. One of its components is the patient's sarcopenia. This can be assessed by measuring the size of the psoas muscle. For this purpose, one of the most studied measures seems to be the measurement of the Psoas Index. This is a contouring of the psoas muscle, performed on an axial section of a CT scan, at the level of the L4 vertebra, which is then matched to the body surface. However, there is no standardization of measurements and volume acquisitions, and different image processing is also described. A radiological evaluation of the psoas could overcome this difficulty and provide a rapid and available screening tool for sarcopenia.
The number of patients suffering from end-stage heart disease challenges healthcare services in the western world, where an estimated 1-2% of the population suffer from this chronic condition. Ventricular assist device (VAD) implantations have become a common therapeutic strategy for those affected. Live with a VAD, however, is far from normal and does expose patients to multiple challenges and the need to adjust to a complex self-management. Inadequate self-management can lead to serious complications, specifically neuro-cognitive events, bleeding, and exit-site related wound infections may impair the outcome following the VAD implantation procedure. Based on systematized literature review and a previous prevalence assessment study (ClinicalTrials.gov Identifier: NCT04234230), a modular evidence-based curriculum has been developed by a multiprofessional group of experts. This curriculum aims at improving knowledge, skills, and competencies for those affected to empower VAD patients to better self-manage their everyday life with the VAD, and to regain quality of life. This study focuses on a multi-center implementation and evaluation of the curriculum using a fully powered randomized-controlled study (RCT) design. This RCT will be conducted at four established cardiac centers throughout Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. At the participating sites, the group assignment is non-blinded to the professionals involved in order to enable the intervention so be carried out adequately. Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). Participants in the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant, and during regular outpatient follow-up. The intervention lasts for 3 months followed by a 9-month follow-up per participant. Based on the power calculations the inclusion of 142 patients is anticipated.
The number of patients with end-stage heart disease requiring the implantation of ventricular assist devices (VAD) is steadily increasing. Living with a VAD exposes the patients to multiple challenges and the need to learn complex self-management skills. Inadequate self-management can lead to serious complications (e.g. bleeding or wound infections) and impair the psychosocial outcome. This study aims to provide multi-centered actual analysis of self-management capabilities as well as analyzing moderating predictors in VAD patients through standardized prevalence assessment. Using a cross-sectional design, this prevalence study will be conducted at four established German heartcenters (Freiburg, Berlin, Bad Oeynhausen, Leipzig). VAD-patients are questioned about their self-management skills using standardized Patient-reported outcome (PRO) measures. Secondary PRO measures include health-related quality of life, symptoms of anxiety and depression, post-traumatic stress symptoms, social support, and changed body-image. Relevant complications (bleeding, wound infections, thromboembolic neurological events) are taken from the patient records. Based on a conservative sample size estimation inclusion of 450 patients is envisioned. The expected results may contribute to an improved assessment of the current situation in terms of self-management skills and needs for curricular training concepts and psychosocial concomitant therapy. Long-term, the study results contribute to improve the health care for long-term VAD patients.
Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. The investigators long term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation. This will be done by addressing the following aims: Aim 1. Identify determinants of center-level variability in HAI rates. Aim 2. Develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates. Aim 3. Develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts. The investigators will use a focused survey of U.S. VAD centers to identify determinants of center variation in 90-day HAI rates: - Process Factors (e.g., intranasal mupirocin), - Provider Factors (e.g., surgeon technique), - Device Factors (e.g., centrifugal vs. axial), - Center Factors (e.g., provider communication). Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted improvement strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation.