Stopping anticoagulants after successful atrial fibrillation ablation with intensive smartwatch monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet 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

Study contacts

• Principal investigator: Changsheng Ma, MD — Beijing Anzhen Hospital
• Study coordinator: Liu He, PhD
• Email: theliu@139.com
• Phone: 13810720787

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.