Automated monitoring for anticoagulation in atrial fibrillation

Pill-in-Pocket Oral Anticoagulation Responding to Atrial Fibrillation Episodes Guided by Continuous Rhythm Monitoring and Automated Smartphone Alerts

This study tests a new way of using automated monitoring to help people with atrial fibrillation manage their blood thinner medication and reduce their risk of stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Oxford University Hospitals NHS Trust (Academic / other)
• Locations: 1 site (Oxford, Oxfordshire)
• Trial ID: NCT06922695 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on patients with atrial fibrillation (AF) and aims to evaluate a pill-in-pocket anticoagulation strategy guided by automated monitoring and alerts. Participants will be monitored for AF episodes and will receive anticoagulation treatment as needed, potentially reducing the risk of stroke associated with AF. The study will include individuals with paroxysmal or persistent AF who meet specific eligibility criteria, including certain health metrics and willingness to manage their anticoagulation therapy. The approach seeks to optimize anticoagulation management and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with non-valvular paroxysmal or persistent atrial fibrillation and a CHA2DS2-VASc score indicating moderate stroke risk.

Not a fit: Patients with contraindications to direct-acting oral anticoagulants or those with mechanical heart valve prostheses may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of stroke in patients with atrial fibrillation.

How similar studies have performed: Other studies have shown promise in using automated monitoring for anticoagulation management, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the trial.
2. Understand the risk and willing to discontinue oral anticoagulation (OAC).
3. Any gender aged 18 years or above.
4. Non-valvular paroxysmal atrial or persistent atrial fibrillation (AF) with a current rhythm control strategy. Paroxysmal patients must have \< 3 documented or symptomatic episodes of \>1 hour duration in the previous 3 months. Persistent patients must have been in continuous sinus rhythm for at least 4 weeks prior to enrolment.
5. CHA2DS2-VASc score between 1 and 3 in men and between 2 and 4 in women.
6. Able to take direct-acting oral anticoagulant (DOAC) in guideline recommended doses.
7. Left atrial (LA) diameter on echocardiogram less than 5 cm (anteroposterior dimensions) or LA volume less than 48 ml/m2.

Exclusion Criteria:

1. Any contraindication to OAC therapy with a DOAC in guideline recommended doses.
2. Mechanical heart valve prosthesis or moderate-to-severe mitral valve stenosis.
3. Permanent atrial fibrillation.
4. Hypertrophic cardiomyopathy.
5. Documented previous thromboembolic event (stroke, transient ischaemic attack or systemic embolism).
6. Spontaneous echo contrast observed in any imaging modality.
7. History of intracardiac thrombi.
8. History of congenital heart disease.
9. Severe chronic renal disease (eGFR \<15 ml/m) or on renal replacement therapy.
10. Pregnant or planning pregnancy.
11. Indication for OAC other than atrial fibrillation.
12. Inability to comply with protocol.
13. Smartphone with operating system (OS) not compatible with MyCareLink Heart app.
14. Contraindication for implantable cardiac monitor.
15. Visual or physical impairment that prevents ability to read and acknowledge smartphone/watch notifications.

Where this trial is running

Oxford, Oxfordshire

• Oxford University Hospitals NHS Trust, John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Prof Tim R. Betts MD MBChB FRCP — University of Oxford
• Study coordinator: Dr Richard K. Varini MBChB MRCPI

Conditions Atrial Fibrillation; Pill-in-pocket anticoagulation; Anticoagulation; As-required anticoagulation; Intermittent anticoagulation