Recruiting
Not applicable
Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation
Condition(s) studied
Atrial Fibrillation (AF)
Investigational drug(s) / intervention(s)
NOAC discontinuationNOAC continuationSmartwatch single-lead ECG monitoring
NOAC discontinuation: Stop NOACs immediately after randomization (experimental arm)
NOAC continuation: Continue guideline-recommended NOAC therapy after randomization (control arm)
Smartwatch single-lead ECG monitoring: Continuous AF screening with a smartwatch capable of recording single-lead ECG, with ECG confirmation required for diagnosis (PPG abnormalities alone are not diagnostic).
Study summary
DIAMOND-AF is a multicenter, randomized, open-label trial evaluating whether discontinuing oral anticoagulation after successful atrial fibrillation ablation can reduce bleeding risk without increasing death or thromboembolism risks. Adults aged 18-80 years, 60-365 days post-ablation, with CHA2DS2-VA ≥2, no prior stroke/TIA/systemic embolism, continuous NOAC use, and no documented atrial tachyarrhythmia recurrence will be randomized 1:1 to stop NOACs immediately or to continue NOAC therapy. All participants use intensified rhythm surveillance including smartwatch ECG and Holter/patch monitoring (at least every 6 months; every 2 months encouraged) to detect recurrence. Co-primary endpoints are (1) non-inferiority for the composite of all-cause death, ischemic stroke, or systemic embolism and (2) superiority for the composite of ISTH major bleeding or ISTH clinically relevant non-major bleeding. The planned sample size is 4,100 participants.
Eligibility
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.
Primary outcome measure(s)
- A composite of all-cause death, ischemic stroke, or systemic embolism — 48 months
The primary effectiveness outcome is to determine whether NOAC discontinuation with intensified rhythm monitoring is non-inferior to continued NOAC therapy for the composite of all-cause death, ischemic stroke, or systematic embolism.
Ischemic stroke is defined as an acute focal dysfunction from CNS infarction lasting ≥24h, with potential hemorrhagic transformation. Systemic embolism refers to arterial embolism or thrombosis (excluding stroke or TIA).
- ISTH major bleeding or ISTH clinically relevant non-major bleeding — 48 months
The primary safety outcome is to determine whether NOAC discontinuation is superior to continued NOAC therapy in reducing the composite of ISTH major bleeding or ISTH clinically relevant non-major bleeding (CRNMB).
ISTH major bleeding and CRNMB are defined per ISTH criteria (e.g., fatal bleeding; critical-site bleeding; hemoglobin drop ≥20 g/L or transfusion ≥2 units for major bleeding; and medically attended, hospitalization-escalating, or unplanned-visit bleeding for CRNMB).
Trial sites (22)
| Facility | City | Region | Status |
| The First Affiliated Hospital of Anhui Medical University |
Hefei |
Anhui |
Not Yet Recruiting |
| Beijing Anzhen Hospital |
Beijing |
Beijing Municipality |
Recruiting |
| Guangdong Provincial People's Hospital |
Guangzhou |
Guangdong |
Not Yet Recruiting |
| The Second Hospital of Hebei Medical University |
Shijiazhuang |
Hebei |
Not Yet Recruiting |
| The First Affiliated Hospital of Harbin Medical University |
Harbin |
Heilongjiang |
Not Yet Recruiting |
| The Second Affiliated Hospital of Harbin Medical University |
Harbin |
Heilongjiang |
Not Yet Recruiting |
| Luohe Central Hospital |
Luohe |
Henan |
Not Yet Recruiting |
| Henan Provincial Chest Hospital |
Zhengzhou |
Henan |
Not Yet Recruiting |
| Wuhan Asia Heart Hospital |
Wuhan |
Hubei |
Not Yet Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology |
Wuhan |
Hubei |
Not Yet Recruiting |
| The First Affiliated Hospital of Nanjing Medical University |
Nanjing |
Jiangsu |
Not Yet Recruiting |
| The Affiliated Hospital of Xuzhou Medical University |
Xuzhou |
Jiangsu |
Not Yet Recruiting |
| The First Hospital of Jilin University |
Changchun |
Jilin |
Not Yet Recruiting |
| First Affiliated Hospital of Dalian Medical University |
Dalian |
Liaoning |
Not Yet Recruiting |
| Shengjing Hospital Affiliated to China Medical University |
Shenyang |
Liaoning |
Not Yet Recruiting |
| Qilu Hospital of Shandong University |
Jinan |
Shandong |
Not Yet Recruiting |
| Liaocheng People's Hospital |
Liaocheng |
Shandong |
Not Yet Recruiting |
| Liaocheng Heart Hospital |
Liaocheng |
Shandong |
Not Yet Recruiting |
| Chengdu Fifth People's Hospital |
Chengdu |
Sichuan |
Not Yet Recruiting |
| The First Affiliated Hospital of Zhejiang University School of Medicine |
Hangzhou |
Zhejiang |
Not Yet Recruiting |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine |
Hangzhou |
Zhejiang |
Not Yet Recruiting |
| Ningbo No.2 Hospital |
Ningbo |
Zhejiang |
Not Yet Recruiting |
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