Overview
The DIAMOND-AF trial, an investigator-initiated multicenter study, randomizes 5,694 stroke-free AF patients with a CHA₂DS₂-VA score of 2-6 post-successful ablation to either smartwatch-guided intermittent direct oral anticoagulant (DOAC) therapy (30-day treatment triggered by AF episodes ≥1 hour single or ≥2 hours/24h) or continuous DOAC therapy. The trial assesses the superiority of intermittent DOAC therapy in reducing major bleeding (ISTH) compared to continuous DOAC therapy, and the non-inferiority of intermittent DOAC in preventing thromboembolism (stroke, embolism, and cardiovascular death) over a 48-month follow-up, aiming to tailor anticoagulation strategies in patients with rhythm control achieved through ablation.
Description
The DIAMOND-AF trial is an investigator-initiated, multicenter, randomized open-label study designed to address anticoagulation uncertainty in 5,694 atrial fibrillation (AF) patients with CHA₂DS₂-VA scores 2-6 who maintain sinus rhythm ≥3 months post-ablation. Participants are randomized 1:1 to receive either NMPA-cleared smartwatch-guided intermittent DOAC (30-day DOAC therapy initiated within 24h of photoplethysmography-detected AF recurrence ≥1-hour single episode or ≥2 hours/24h) or continuous DOAC therapy per current guidelines. The co-primary endpoints evaluate: 1) superiority in reducing ISTH-defined major bleeding events over 48 months, and 2) non-inferiority in preventing composite thromboembolism (ischemic stroke, systemic embolism, and cardiovascular death). Endpoints were assessed through blinded endpoint adjudication committees. This trial pioneers an individualized medicine approach by integrating consumer-grade wearable technology with dynamic anticoagulation, potentially tailoring post-ablation management for high-risk AF populations through dual validation of both arrhythmia detection accuracy (PPG vs ECG) and event-driven anticoagulation efficacy.
Eligibility
Inclusion Criteria:
- Age 18-80 years.
- No recurrence of atrial arrhythmia within 3 months after the most recent AF/atrial flutter catheter ablation.
- CHA₂DS₂-VA score of 2-6.
- Voluntarily sign informed consent to participate in the study.
- Willingness and ability to comply with the study protocol.
Exclusion Criteria:
- 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.
- Premature atrial complex or premature ventricular complex burden >10% on any 24-hour Holter within 3 months after ablation.
- Moderate-to-severe mitral stenosis (mitral valve area ≤ 2.0 cm²) or mechanical heart valves.
- History of stroke, transient ischemic attack, systemic embolism, or left atrial thrombus.
- Conditions associated with an increased risk of bleeding:
- History of major non-traumatic bleeding events (e.g., intracranial, intraocular, retroperitoneal, gastrointestinal, or intra-articular bleeding), unless reversible causes have been permanently eliminated;
- Untreated intracranial aneurysms, vascular malformations, or gastrointestinal ulcers;
- Surgery involving general anesthesia within the last 3 months or planned surgery within the next 3 months;
- Bleeding disorders (e.g., hemophilia);
- Uncontrolled hypertension (systolic BP > 180 mmHg or diastolic BP > 110 mmHg);
- Hemoglobin < 90 g/L or history of blood transfusion within 4 weeks prior to enrollment;
- Severe thrombocytopenia (platelet count < 50 × 10⁹/L);
- Stage 5 chronic kidney disease (eGFR < 15 ml/min/1.73m²) or dialysis;
- Severe liver disease (e.g., esophageal varices, ascites, hepatic encephalopathy, or jaundice);
- Known intolerance or contraindications to DOACs.
- Presence of a cardiac implantable electronic device or indication for a permanent
pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
- Conditions requiring long-term anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, or amyloidosis).
- High risk for non-cardiogenic stroke (e.g., carotid artery stenosis > 70%).
- Currently on warfarin and unwilling or unable to switch to a DOAC.
- Currently on dual antithrombotic therapy (e.g., dual antiplatelet therapy or anticoagulant plus antiplatelet therapy).
- Left atrial appendage (LAA) occlusion, LAA closure, or confirmed LAA electrical isolation.
- Woman who is pregnant and/or breastfeeding.
- Life expectancy of less than 2 years.
- 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.
- Participation in another interventional clinical trial.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.