DIscontinuation of Anticoagulation Guided by Smartwatch in Post-ablation Patients with Atrial Fibrillation

Launched by BEIJING ANZHEN HOSPITAL · Mar 5, 2025

Keywords

ClinConnect Summary

The DIAMOND-AF trial is a study designed to explore the best way to manage blood-thinning medications for patients with atrial fibrillation (AF) who have recently undergone a procedure called ablation. In this trial, 5,694 participants who are at risk for stroke will be divided into two groups. One group will use a smartwatch to guide when they take their blood-thinning medication (called direct oral anticoagulants or DOACs) based on their heart activity, while the other group will take this medication continuously. The goal is to see if using the smartwatch can help reduce the risk of serious bleeding and if it can still prevent strokes and other cardiovascular issues effectively.

To be eligible for this study, participants must be between 18 and 80 years old, have not experienced any heart rhythm issues in the last three months after their ablation, and have a specific score that indicates their risk for stroke. Those who join the study will be closely monitored for 48 months to ensure their safety and to track the effectiveness of the different medication strategies. It's important for potential participants to be aware of specific health conditions that may exclude them from the trial, such as a history of major bleeding or certain heart issues. Overall, this trial aims to personalize treatment for patients with AF to improve their health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-80 years.
• • 2. No recurrence of atrial arrhythmia within 3 months after the most recent AF/atrial flutter catheter ablation.
• • 3. CHA₂DS₂-VA score of 2-6.
• • 4. Voluntarily sign informed consent to participate in the study.
• • 5. Willingness and ability to comply with the study protocol.
• Exclusion Criteria:
• • 1. Non-compliance with prescribed DOACs or antiarrhythmic drugs (AADs), or failure to undergo protocol-mandated 24-hour Holter monitoring for rhythm assessment within 3 months post-ablation.
• • 2. Premature atrial complex or premature ventricular complex burden \>10% on any 24-hour Holter within 3 months after ablation.
• • 3. Moderate-to-severe mitral stenosis (mitral valve area ≤ 2.0 cm²) or mechanical heart valves.
• • 4. History of stroke, transient ischemic attack, systemic embolism, or left atrial thrombus.
• 5. Conditions associated with an increased risk of bleeding:
• • 1. History of major non-traumatic bleeding events (e.g., intracranial, intraocular, retroperitoneal, gastrointestinal, or intra-articular bleeding), unless reversible causes have been permanently eliminated;
• • 2. Untreated intracranial aneurysms, vascular malformations, or gastrointestinal ulcers;
• • 3. Surgery involving general anesthesia within the last 3 months or planned surgery within the next 3 months;
• • 4. Bleeding disorders (e.g., hemophilia);
• • 5. Uncontrolled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 110 mmHg);
• • 6. Hemoglobin \< 90 g/L or history of blood transfusion within 4 weeks prior to enrollment;
• • 7. Severe thrombocytopenia (platelet count \< 50 × 10⁹/L);
• • 8. Stage 5 chronic kidney disease (eGFR \< 15 ml/min/1.73m²) or dialysis;
• • 9. Severe liver disease (e.g., esophageal varices, ascites, hepatic encephalopathy, or jaundice);
• • 10. Known intolerance or contraindications to DOACs.
• • 6. Presence of a cardiac implantable electronic device or indication for a permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
• • 7. Conditions requiring long-term anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, or amyloidosis).
• • 8. High risk for non-cardiogenic stroke (e.g., carotid artery stenosis \> 70%).
• • 9. Currently on warfarin and unwilling or unable to switch to a DOAC.
• • 10. Currently on dual antithrombotic therapy (e.g., dual antiplatelet therapy or anticoagulant plus antiplatelet therapy).
• • 11. Left atrial appendage (LAA) occlusion, LAA closure, or confirmed LAA electrical isolation.
• • 12. Woman who is pregnant and/or breastfeeding.
• • 13. Life expectancy of less than 2 years.
• • 14. Presence of tattoos, birthmarks, surgical scars, or tremors (e.g., Parkinson's disease, benign essential tremor) in the wrist area that may interfere with PPG monitoring.
• • 15. Participation in another interventional clinical trial.
• • 16. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.