ANZCTR search results

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat severe aortic stenosis. A common problem after TAVI is disruption of the heart’s electrical system, which can cause the heart rate to slow and may require a permanent pacemaker. Irregular heart rhythms, such as atrial fibrillation can also occur and may require blood-thinning medication to reduce the long-term risk of stroke. In this study, all patients undergoing TAVI at two centres in Sydney, Australia will receive extended heart rhythm monitoring for 28 days before their procedure. After TAVI, they will be randomly assigned to either standard care, with no routine rhythm monitoring after discharge, or a further 28 days of extended heart rhythm monitoring. Patients will be followed up at 1 month and 1 year after TAVI. The study aims to improve our understanding of baseline conduction disease in severe aortic stenosis and the utility of extended ambulatory monitoring for earlier detection of important rhythm disturbances after TAVI. This can help refine periprocedural risk stratification, inform targeted surveillance and support early discharge pathways.

This study is Part 2 of this Phase 1 study. Part 1 is ACTRN12626000320358. Part 2 evaluates the effect of famotidine, on the PK and safety of ATH434 in healthy volunteers. The primary hypothesis is that co-administration of famotidine will not significantly change the systemic exposure of a single 75 mg dose of ATH434. The study also aims to confirm the safety and tolerability of combining these treatments, using a fixed-sequence crossover design to compare ATH434 levels with and without famotidine. The timing of famotidine dosing relative to ATH434 is adaptive and may be altered based on emerging data from Part 1. The proposed famotidine dose timing is either 10 hours before ATH434 dosing or 2 hours after.

This study will evaluate whether providing several rapid sexually transmitted infection (STI) tests together during a single clinic visit can improve timely diagnosis and treatment for people who may experience barriers to accessing conventional sexual health services. Participants attending the Access Health clinic will be offered point-of-care testing for HIV, syphilis, chlamydia and gonorrhoea, with Mycoplasma genitalium testing offered where clinically indicated, alongside routine laboratory testing. The study will assess whether this approach is feasible and acceptable, how well the point-of-care results agree with routine laboratory results, and whether people with a positive chlamydia, gonorrhoea or Mycoplasma genitalium result can start appropriate treatment during the same visit. It will also examine the experiences of participants and service providers, as well as the costs and practical requirements of delivering the service. We expect that integrating multiple point-of-care tests into the clinic will support faster result delivery and same-visit treatment where appropriate, while providing evidence about whether this model could be sustained and expanded in similar services.

This project aims to co-design, deliver and evaluate to pilot stage, a health service integration program, The Youth Service Integration Resource Kit to improve integrated mental health care for young people. This pilot feasibility RCT study is a second phase installment. This pilot feasibility RCT will evaluate the refined Resource Kit to assess the feasibility and implementation with headspace and LHD centers and other community-based mental health services and if acceptability will be sufficient to recommend if a definitive national trial is warranted. We will recruit participants from ten sites from headspace and corresponding LHD’s. From these sites we will recruit and consent staff, clinical managers and clinicians. Phase 2 will also include recruitment and focus groups with headspace clients.

In this project we will implement a CYP2C19 genetic testing service in patients who are undergoing percutaneous coronary intervention, to guide antiplatelet therapy and reduce the risk of recurrent ischaemic events. The aim of the project is primarily to investigate adoption of the service in routine practice. Secondary aims are to determine clinical efficacy and cost-effectiveness.

Central venous catheters are commonly inserted in critically ill patients to give medications and other treatments. A chest X-ray is routinely used to confirm that the catheter is correctly positioned and to check for complications, but waiting for an X-ray may delay use of the catheter. This study will investigate whether bedside point-of-care ultrasound can accurately and more rapidly confirm central venous catheter placement in adult intensive care patients compared with standard chest X-ray confirmation. Participants will be randomly allocated to either standard chest X-ray confirmation alone or bedside ultrasound assessment in addition to standard chest X-ray confirmation. The study will assess the accuracy and speed of ultrasound confirmation, its ability to identify complications such as pneumothorax, agreement between ultrasound operators, protocol adherence, and potential effects on healthcare costs and clinical workflow.

Epidural analgesia is a common choice for women in labour. There is no evidence about how to best manage the positioning of a woman once an epidural has been placed. When no epidural is used, evidence supports upright positioning in labour, but this is not the case for women with an epidural where the opposite is true. We aim to fill an important gap in the literature about the management of a woman’s position when using an epidural to maximise safe and spontaneous vaginal birth. We are proposing a randomised controlled trial comparing usual care with structured position changes from side to side every hour and assessing the effect on spontaneous vaginal birth, as well as other important maternal and neonatal outcomes, and maternal experiences in labour.

Background: Youth aged 14–24 years’ experience more concussions than any age group in Australia, coinciding with a critical neurodevelopmental period. The debilitating signs and symptoms interfere with school, sport, and daily activities. In 30% of cases patients have persistent and intractable effects lasting months to years, affecting mental health and impairing quality of life. Problem: There is a scarcity of effective treatments to mitigate and prevent the effects of a concussion. Australians, The Australian Senate, and international research groups are urging scientific investigations into clinical solutions. Solution: This project seeks to accelerate clinical trials in novel neuroprotective strategies. It will assess the potential and feasibility of an innovative and safe standardised soccer heading model to establish proof-of-concept for neuroprotective strategies in up to 80 male and female youth. This project is informed by a previous clinical pilot trial led by CI Delang. Impact: The clinical research model will facilitate rapid determination of proof-of-concept neuroprotective strategies in future trials, which our team of neurologists, physicians, dietitians, exercise physiologists, physiotherapists, biomedical engineers and statisticians are expertly positioned to conduct.

This study tests a new computer program called "Focal Finder," designed to quickly identify the precise source of certain fast heart rhythms (focal atrial tachycardia). During standard ablation procedures, locating these sources can be time-consuming, and the arrhythmia sometimes stops before a complete map is obtained. Focal Finder may be able to pinpoint the source from only a small number of measurements. To validate accuracy, researchers pace the heart from known locations during procedures that patients are already undergoing for clinical reasons. Because the exact pacing location is known, the team can measure how accurately the algorithm identifies it. The research component (additional pacing sequences) is performed after the clinical procedure is completed, before catheters are removed, and adds approximately 20–40 minutes. No additional procedures, needle insertions, or drugs are involved.

Atrial fibrillation (AF) is the most common heart rhythm problem and a frequent reason for emergency department (ED) visits. Many patients with AF who come to the ED will spontaneously return to a normal heart rhythm on their own — a process called spontaneous cardioversion (SCV) — without needing active treatment. However, because clinicians currently cannot reliably predict which patients will revert naturally, most AF patients are admitted to hospital for monitoring and treatment, which leads to unnecessary hospitalisations. This study, called PREVAIL-AF, tests whether an artificial intelligence (AI) tool that analyses a patient's electrocardiogram (ECG, or heart tracing) can accurately predict which patients are likely to have SCV. The AI tool was previously trained using ECG data from a prior study at the same hospital. In PREVAIL-AF, the AI tool's prediction will be used to guide whether a patient is safely discharged home from the ED under a structured "wait-and-see" plan (with heart rate medications, blood thinners, and a follow-up cardiology appointment within 7 days), or admitted to hospital for standard care. This is a first-in-human pilot study aimed at testing whether this approach is feasible, safe, and accurate. The results will help refine the AI model and design a larger multi-centre study in the future. The study will be conducted at Flinders Medical Centre in Adelaide, South Australia.