Stopping anticoagulants after successful atrial fibrillation ablation with intensive smartwatch monitoring

DIscontinuation of Anticoagulation With Intensive Rhythm MONitoring CompareD With Continuous Anticoagulation in Post-ablation Patients With Atrial Fibrillation: A Randomized Controlled Trial

This trial will test whether adults 18–80 who are 60–365 days after a successful AF ablation and have been on a NOAC can safely stop their blood thinner while using frequent smartwatch and patch monitoring, aiming to lower bleeding without raising stroke or embolism risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 4100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 22 sites (Hefei, Anhui and 21 other locations)
• Trial ID: NCT06871228 on ClinicalTrials.gov

What this trial studies

DIAMOND-AF is a multicenter, randomized, open-label trial that randomly assigns eligible post-ablation patients 1:1 to either stop their non-vitamin K oral anticoagulant immediately or continue it. All participants receive intensified rhythm surveillance with a single-lead ECG-capable smartwatch plus scheduled Holter/patch monitoring (at least every 6 months, encouraged every 2 months) and symptom-triggered ECGs to detect AF recurrence. The study uses co-primary endpoints: non-inferiority for a composite of all-cause death, ischemic stroke, or systemic embolism, and superiority for a composite of ISTH major or clinically relevant non-major bleeding. The planned enrollment is 4,100 participants across several major cardiac centers in China.

Who should consider this trial

Good fit: Adults 18–80 years old who are 60–365 days after AF/AFL ablation, have CHA2DS2-VA ≥2, no prior stroke/TIA/systemic embolism, have been on a NOAC continuously since ablation, and have no documented atrial tachyarrhythmia recurrence are ideal candidates.

Not a fit: Patients with prior stroke/TIA or systemic embolism, evidence of post-ablation arrhythmia recurrence, high recurrence risk features, mechanical valves, moderate-to-severe mitral stenosis, or other exclusionary bleeding risks are unlikely to benefit from stopping anticoagulation in this protocol.

Why it matters

Potential benefit: If successful, the approach could allow some patients to stop long-term anticoagulation after ablation and reduce bleeding complications while maintaining low stroke risk.

How similar studies have performed: Observational studies have suggested low stroke rates after durable ablation, but randomized evidence with intensive wearable monitoring to guide anticoagulation discontinuation is limited and this approach is relatively novel.

Eligibility criteria

Inclusion Criteria

Participants must meet all of the following criteria:

1. Age 18 to 80 years.
2. 60±15 to 365±15 days after atrial fibrillation/atrial flutter (AF/AFL) ablation.
3. CHA2DS2-VA score ≥2.
4. No history of stroke, transient ischemic attack (TIA), or systemic embolism.
5. Continuous use of a NOAC since AF/AFL ablation.
6. No documented atrial tachyarrhythmia recurrence since ablation.
7. No antiarrhythmic drug (AAD) use within the past 2 months.
8. Able and willing to provide written informed consent.
9. Able and willing to comply with study procedures and follow-up.

Exclusion Criteria

Participants will be excluded if any of the following criteria are present:

1. High risk of post-ablation recurrence (e.g. including premature atrial contraction burden \>3% on any ambulatory ECG/Holter recording).
2. Moderate-to-severe mitral stenosis (mitral valve area ≤2.0 cm²) or mechanical heart valve.
3. Increased bleeding risk, including any of the following:

   1. Current ISTH major bleeding or clinically relevant non-major bleeding (CRNMB).
   2. History of non-traumatic major bleeding (e.g., intracranial, intraocular, spinal, retroperitoneal, gastrointestinal, or intra-articular) unless the reversible cause has been permanently eliminated.
   3. Unresolved intracranial aneurysm/vascular malformation, or active/unhealed gastric or duodenal ulcer.
   4. General anesthesia surgery within the past 3 months.
   5. Planned surgery within the next 3 months.
   6. Known bleeding diathesis (e.g., hemophilia).
   7. Uncontrolled hypertension (SBP \>180 mmHg and/or DBP \>110 mmHg).
   8. Hemoglobin \<90 g/L or blood transfusion within 4 weeks prior to enrollment.
   9. Platelet count \<50 × 10⁹/L.
   10. End-stage kidney disease (eGFR \<15 mL/min/1.73 m²) or on dialysis.
   11. Severe liver disease (e.g., esophageal variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
   12. Known intolerance to oral anticoagulants or contraindication to oral anticoagulation.
4. Any condition requiring continued oral anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, cardiac amyloidosis).
5. Conditions associated with high non-cardioembolic stroke risk, including carotid, vertebral, or intracranial arterial stenosis ≥70%.
6. Prior left atrial appendage (LAA) occlusion, surgical LAA excision/closure, or intraoperative confirmation of LAA electrical isolation.
7. Female participants who are pregnant or breastfeeding, or of childbearing potential not using effective contraception.
8. Life expectancy \<2 years.
9. Current participation in another interventional clinical trial.
10. Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.

Where this trial is running

Hefei, Anhui and 21 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Luohe Central Hospital — Luohe, Henan, China (Not_yet_recruiting)
• Henan Provincial Chest Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Wuhan Asia Heart Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital Affiliated to China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Not_yet_recruiting)
• Liaocheng Heart Hospital — Liaocheng, Shandong, China (Not_yet_recruiting)
• Chengdu Fifth People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Ningbo No.2 Hospital — Ningbo, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Changsheng Ma, MD — Beijing Anzhen Hospital
• Study coordinator: Liu He, PhD

Conditions Atrial Fibrillation; atrial fibrillation; catheter ablation; smartwatch; anticoagulation; thromboembolism; bleeding