Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation
Recruiting · NCT06871228 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Anzhen Hospital
View the official record on ClinicalTrials.gov →Interventions studied
NOAC continuationNOAC discontinuationSmartwatch single-lead ECG monitoring
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must meet all of the following criteria:
- Age 18 to 80 years.
- 60±15 to 365±15 days after atrial fibrillation/atrial flutter (AF/AFL) ablation.
- CHA2DS2-VA score ≥2.
- No history of stroke, transient ischemic attack (TIA), or systemic embolism.
- Continuous use of a NOAC since AF/AFL ablation.
- No documented atrial tachyarrhythmia recurrence since ablation.
- No antiarrhythmic drug (AAD) use within the past 2 months.
- Able and willing to provide written informed consent.
- 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:
- High risk of post-ablation recurrence (e.g. including premature atrial contraction burden \>3% on any ambulatory ECG/Holter recording).
- Moderate-to-severe mitral stenosis (mitral valve area ≤2.0 cm²) or mechanical heart valve.
- Increased bleeding risk, including any of the following:
- Current ISTH major bleeding or clinically relevant non-major bleeding (CRNMB).
- History of non-traumatic major bleeding (e.g., intracranial, intraocular, spinal, retroperitoneal, gastrointestinal, or intra-articular) unless the reversible cause has been permanently eliminated.
- Unresolved intracranial aneurysm/vascular malformation, or active/unhealed gastric or duodenal ulcer.
- General anesthesia surgery within the past 3 months.
- Planned surgery within the next 3 months.
- Known bleeding diathesis (e.g., hemophilia).
- Uncontrolled hypertension (SBP \>180 mmHg and/or DBP \>110 mmHg).
- Hemoglobin \<90 g/L or blood transfusion within 4 weeks prior to enrollment.
- Platelet count \<50 × 10⁹/L.
- End-stage kidney disease (eGFR \<15 mL/min/1.73 m²) or on dialysis.
- Severe liver disease (e.g., esophageal variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
- Known intolerance to oral anticoagulants or contraindication to oral anticoagulation.
- Any condition requiring continued oral anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, cardiac amyloidosis).
- Conditions associated with high non-cardioembolic stroke risk, including carotid, vertebral, or intracranial arterial stenosis ≥70%.
- Prior left atrial appendage (LAA) occlusion, surgical LAA excision/closure, or intraoperative confirmation of LAA electrical isolation.
- Female participants who are pregnant or breastfeeding, or of childbearing potential not using effective contraception.
- Life expectancy \<2 years.
- Current participation in another interventional clinical trial.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.
Where it is running
22 locations listed.
- The First Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- Beijing Anzhen Hospital - Beijing, Beijing Municipality, China
- Guangdong Provincial People's Hospital - Guangzhou, Guangdong, China
- The Second Hospital of Hebei Medical University - Shijiazhuang, Hebei, China
- The First Affiliated Hospital of Harbin Medical University - Harbin, Heilongjiang, China
- The Second Affiliated Hospital of Harbin Medical University - Harbin, Heilongjiang, China
- Luohe Central Hospital - Luohe, Henan, China
- Henan Provincial Chest Hospital - Zhengzhou, Henan, China
- Wuhan Asia Heart Hospital - Wuhan, Hubei, China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- The First Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China
- The Affiliated Hospital of Xuzhou Medical University - Xuzhou, Jiangsu, China
- The First Hospital of Jilin University - Changchun, Jilin, China
- First Affiliated Hospital of Dalian Medical University - Dalian, Liaoning, China
- Shengjing Hospital Affiliated to China Medical University - Shenyang, Liaoning, China
- Qilu Hospital of Shandong University - Jinan, Shandong, China
- Liaocheng People's Hospital - Liaocheng, Shandong, China
- Liaocheng Heart Hospital - Liaocheng, Shandong, China
- Chengdu Fifth People's Hospital - Chengdu, Sichuan, China
- The First Affiliated Hospital of Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Hangzhou, Zhejiang, China
- Ningbo No.2 Hospital - Ningbo, Zhejiang, China