RESPOND-AF
Research type
Research Study
Full title
'Pill-in-Pocket' Oral Anticoagulation Responding to Atrial Fibrillation Episodes Guided by Continuous Rhythm Monitoring and Automated Smartphone Alerts
IRAS ID
329237
Contact name
Tim R Betts
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Atrial Fibrillation (AF) is the most common cardiac arrhythmia and carries an increased risk of stroke. Stroke risk is commonly assessed using the CHA2DS2-VASC scoring system.
To reduce stroke risk, guidelines advise AF patients with higher CHA2DS2-VASC scores be treated with oral anticoagulation (OAC), also known as blood thinning medication. OAC reduces the stroke risk, however it also increases the risk of bleeding episodes, which can be major and life-threatening.
AF patterns can vary between patients. One patient may have only one 10-minute episode of AF per year, while another may have dozens of episodes lasting hours or days. The guidelines advising daily, lifelong OAC do not distinguish between these patients.
However, there is evidence suggesting stroke risk is higher in patients with longer, more frequent AF episodes. There is also evidence that stroke risk increases following an episode of AF, returning to baseline risk after 30 days.
For these reasons, we designed the RESPOND-AF trial to assess a new approach, whereby patients only take OAC in response to an AF episode. 30 days after the AF episode ends, the patient stops taking OAC. The aim is to reduce OAC usage for patients, thereby reducing their risk of major bleeding episodes, while maintaining effective blood-thinning when AF occurs.
In RESPOND-AF, patients have a small Implantable Cardiac Monitor (ICM) inserted under their skin on the chest. The LINQ-II™ ICM device (Medtronic) connects directly with patients’ smartphones via low-energy BlueSync™ technology. In RESPOND-AF, uniquely, any qualifying episode of AF will trigger an automated smartphone notification to promptly start daily OAC until they are free of AF for 30 days.
The study will be conducted at John Radcliffe Hospital, Oxford. Participants will be actively enrolled for a 12-month treatment period. RESPOND-AF has received financial sponsorship from Medtronic.REC name
West of Scotland REC 1
REC reference
24/WS/0126
Date of REC Opinion
10 Jan 2025
REC opinion
Further Information Favourable Opinion