Clinical trial NCT06871228: DIscontinuation of Anticoagulation Guided by Smartwatch in Post-ablation Patients With Atrial Fibrillation
Official title: DIscontinuation of Anticoagulation MONitoreD by Smartwatch Versus Continuous Anticoagulation in Post-ablation Patients With Atrial Fibrillation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: atrial fibrillation
catheter ablation
smartwatch
anticoagulation
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 5694
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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.

Primary outcomes:
measure: To assess whether smartwatch-guided, tailored DOAC therapy is superior to continuous DOAC therapy in reducing major bleeding and non-inferior in preventing a composite endpoint of: (1) ischemic stroke, (2) systemic embolism, and (3) cardiovascular death.
timeFrame: over 48 months
Secondary outcomes:
measure: Ischemic stroke
timeFrame: over 48 months
measure: Systemic embolism
timeFrame: 48 months
measure: Cardiovascular death
timeFrame: 48 months
measure: Major bleeding
timeFrame: 48 months
measure: All-cause death
timeFrame: 48 months
measure: Clinically relevant non-major bleeding
timeFrame: 48 months
measure: Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT) score
timeFrame: 48 months
measure: Five-Level EuroQol Five Dimensions Questionnaire (EQ-5D-5L) score
timeFrame: 48 months
measure: Generalized Anxiety Disorder-7 item questionnaire (GAD-7) score
timeFrame: 48 months
measure: Patient Health Questionnaire-9 item questionnaire (PHQ-9) score
timeFrame: 48 months
measure: Total time of using DOAC
timeFrame: 48 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luohe
country: China
facility: Luohe Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial Chest Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Beijing Anzhen Hospital
name: Changsheng Ma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Caihua Sang
role: PRINCIPAL_INVESTIGATOR
References: