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Clinical trial completes recruitment ahead of schedule

27 June 2018


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A Trust-led research study comparing ablation techniques in patients with atrial fibrillation (AF), has managed to meet its recruitment target one month ahead of schedule.


The study was led by Dr Tom Wong, who credited the success to the optimum performance of all sites, access to patients and good scheduling.


This flagship study from the founding members of the Institute of Cardiovascular Medicine and Science (ICMS) saw 120 patients recruited from Royal Brompton and Harefield hospitals, Liverpool Heart and Chest Hospital and Brighton and Sussex University Hospitals, in just 33 months.


In this study, two forms of ablation are being compared, catheter ablation and thoracoscopic surgical ablation, in patients who have long-standing persistent AF (which causes irregular and often abnormally fast heart rate) and who have tried and failed drug and/or electrical therapy. The condition can lead to an increased risk of stroke and heart failure which is why treatment is so important.


The project was not without some challenges, in particular, accessing suitable patients who could be eligible for the trial. To counter this, the team ensured that patients were pre-screened at patient referral centres with all suitable patients contacted to see if they would be willing to participate in the study.


In addition, careful pre-screening against the main inclusion exclusion criteria ensured that patient baseline appointments were offered only to those with the best chance of successfully passing screening, minimising screening-failures.


Scheduling also proved to be a challenge for the research team where on occasion some of the imaging assessments, required to confirm patient study eligibility, were not available, with clinical appointments taking priority. Under these circumstances, the clinical teams at the sites were incredibly flexible and worked together to open additional appointment slots, often early in the morning, to ensure study patients were seen at the earliest opportunity.


With this combined support, Liverpool Heart and Chest Hospital managed to recruit 18 patients to the trial and Brighton and Sussex University Hospitals secured 5 patients. A total of 58 patients were recruited from Royal Brompton Hospital with a further 39 patients from Harefield Hospital.


When asked what tips the research team had for other clinical trials, Matt Gill, who managed this multi-centre trial, insisted there are no quick fixes or trade secrets when it comes to recruiting successfully.


“For any clinical trial its important there is continuous and consistent communication between the staff across the sites. It’s also important to set monthly targets and provide weekly recruitment updates to keep everyone informed of progress. Of course the most important thing is having a team that works incredibly hard.


“I’m absolutely delighted that we have completed recruitment for this important study. Reaching such a milestone would not have been possible without a lot of hard work from a highly dedicated and talented team across the sites”.


Results from this National Institute for Health (NIHR) funded study are expected to be published in December 2019.


If you would like to find out more about any of our research, please email research-findoutmore@rbht.nhs.uk.

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