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

Last updated: March 2, 2026
Sponsor: Beijing Anzhen Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Hemorrhage

Atrial Fibrillation

Treatment

PPG/ECG dual mode based smartwatch

Continuous DOAC therapy

Smartwatch single-lead ECG monitoring

Clinical Study ID

NCT06871228
2025KLS09
  • Ages 18-80
  • All Genders

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 Criteria

Inclusion

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:

  4. Current ISTH major bleeding or clinically relevant non-major bleeding (CRNMB).

  5. History of non-traumatic major bleeding (e.g., intracranial, intraocular, spinal, retroperitoneal, gastrointestinal, or intra-articular) unless the reversible cause has been permanently eliminated.

  6. Unresolved intracranial aneurysm/vascular malformation, or active/unhealed gastric or duodenal ulcer.

  7. General anesthesia surgery within the past 3 months.

  8. Planned surgery within the next 3 months.

  9. Known bleeding diathesis (e.g., hemophilia).

  10. Uncontrolled hypertension (SBP >180 mmHg and/or DBP >110 mmHg).

  11. Hemoglobin <90 g/L or blood transfusion within 4 weeks prior to enrollment.

  12. Platelet count <50 × 10⁹/L.

  13. End-stage kidney disease (eGFR <15 mL/min/1.73 m²) or on dialysis.

  14. Severe liver disease (e.g., esophageal variceal bleeding, ascites, hepatic encephalopathy, or jaundice).

  15. Known intolerance to oral anticoagulants or contraindication to oral anticoagulation.

  16. Any condition requiring continued oral anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, cardiac amyloidosis).

  17. Conditions associated with high non-cardioembolic stroke risk, including carotid, vertebral, or intracranial arterial stenosis ≥70%.

  18. Prior left atrial appendage (LAA) occlusion, surgical LAA excision/closure, or intraoperative confirmation of LAA electrical isolation.

  19. Female participants who are pregnant or breastfeeding, or of childbearing potential not using effective contraception.

  20. Life expectancy <2 years.

  21. Current participation in another interventional clinical trial.

  22. Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.

Study Design

Total Participants: 4100
Treatment Group(s): 5
Primary Treatment: PPG/ECG dual mode based smartwatch
Phase:
Study Start date:
August 05, 2025
Estimated Completion Date:
December 31, 2029

Study Description

DIAMOND-AF is an investigator-initiated, multicenter, randomized, open-label, parallel-group trial designed to evaluate post-catheter ablation anticoagulation management in patients with atrial fibrillation (AF/AFL). The trial will enroll adults aged 18-80 years who are 60±15 to 365±15 days after AF ablation, have a CHA2DS2-VA score ≥2, have no history of ischemic stroke/transient ischemic attack/systemic embolism, have been continuously taking a non-vitamin K antagonist oral anticoagulant (NOAC), and have no documented atrial tachyarrhythmia recurrence after ablation. Eligible participants will be randomized 1:1 to (1) discontinue NOAC immediately after randomization or (2) continue NOAC therapy. The study uses a co-primary endpoint strategy: a non-inferiority assessment for the composite efficacy endpoint (all-cause death, ischemic stroke, or systemic embolism) and a superiority assessment for the composite safety endpoint (ISTH major bleeding or ISTH clinically relevant non-major bleeding). To maximize safety while testing an anticoagulation-discontinuation strategy, all participants will undergo intensified rhythm monitoring using a smartwatch capable of single-lead ECG plus scheduled Holter/single-lead ECG patch monitoring (at least every 6 months; every 2 months encouraged), with symptom-triggered and opportunistic ECGs incorporated. AF Recurrence is defined as any ECG-confirmed atrial tachyarrhythmia (AF/AFL/atrial tachycardia) lasting ≥30 seconds; once AF recurrence is confirmed, the participant will be censored and will exit further trial follow-up. Participants will have in-person/structured study visits at months 3 and 6 after randomization, then every 6 months, with additional rhythm/anticoagulation follow-up every 2 months. The planned sample size is 4,100 participants (2,050 per group).

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei 1808722, Anhui 1818058 230022
    China

    Site Not Available

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality 100029
    China

    Active - Recruiting

  • Beijing Anzhen Hospital

    Beijing 1816670, Beijing Municipality 2038349 100029
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang 1795270, Hebei 1808773 050000
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150085
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin 2037013, Heilongjiang 2036965 150001
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin 2037013, Heilongjiang 2036965 150085
    China

    Site Not Available

  • Luohe Central Hospital

    Luohe, Henan 462003
    China

    Site Not Available

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Luohe Central Hospital

    Luohe 1801934, Henan 1808520 462003
    China

    Site Not Available

  • Henan Provincial Chest Hospital

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • Wuhan Asia Heart Hospital

    Wuhan 1791247, Hubei 1806949 430022
    China

    Site Not Available

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210036
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221002
    China

    Site Not Available

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing 1799962, Jiangsu 1806260 210036
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou 10630003, Jiangsu 1806260 221002
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130021
    China

    Site Not Available

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116023
    China

    Site Not Available

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • First Affiliated Hospital of Dalian Medical University

    Dalian 1814087, Liaoning 2036115 116023
    China

    Site Not Available

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang 2034937, Liaoning 2036115 110004
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Liaocheng Heart Hospital

    Liaocheng, Shandong 252299
    China

    Site Not Available

  • Liaocheng People's Hospital

    Liaocheng, Shandong 252000
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan 1805753, Shandong 1796328 250012
    China

    Site Not Available

  • Liaocheng Heart Hospital

    Liaocheng 1803834, Shandong 1796328 252299
    China

    Site Not Available

  • Liaocheng People's Hospital

    Liaocheng 1803834, Shandong 1796328 252000
    China

    Site Not Available

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan 611130
    China

    Site Not Available

  • Chengdu Fifth People's Hospital

    Chengdu 1815286, Sichuan 1794299 611130
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang 315000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310009
    China

    Site Not Available

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