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Recruiting Not applicable

Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation

NCT06871228 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-08-05
Last updated
2026-03-04

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06871228 on ClinicalTrials.gov ↗ ← All trials in China