Stopping Blood Thinners After Heart Rhythm Ablation in Atrial Fibrillation

Trial details

Who runs it

Beijing Anzhen Hospital

Trial code

NCT06871228

Record updated

4 March 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: Prior left atrial appendage (LAA) occlusion, surgical LAA excision/closure, or intraoperative confirmation of LAA electrical isolation; Moderate-to-severe mitral stenosis (mitral valve area ≤2.0 cm²) or mechanical heart valve; 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%; Any condition that, in the investigator's judgment, would make the participant unsuitable for the study; 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; Life expectancy <2 years; 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); Female participants who are pregnant or breastfeeding, or of childbearing potential not using effective contraception; Current participation in another interventional clinical trial.

ClinicalTrials.gov NCT06871228