Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation (DIAMOND-AF)

March 2, 2026 updated by: Beijing Anzhen Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

4100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Caihua Sang, MD

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Ronghui Yu
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Principal Investigator:
          • Changsheng Ma
        • Contact:
        • Principal Investigator:
          • Caihua Sang
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Xianhong Fang
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
        • Principal Investigator:
          • Jinming Liu
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Not yet recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Principal Investigator:
          • Yue Li
        • Contact:
      • Harbin, Heilongjiang, China, 150085
        • Not yet recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Principal Investigator:
          • Bo Yu
        • Contact:
    • Henan
      • Luohe, Henan, China, 462003
        • Not yet recruiting
        • Luohe Central Hospital
        • Contact:
        • Principal Investigator:
          • Jirui Cai
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Provincial Chest Hospital
        • Contact:
        • Principal Investigator:
          • Yiqiang Yuan
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Yan Wang
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Wuhan Asia Heart Hospital
        • Principal Investigator:
          • Hua Yan
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210036
        • Not yet recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Xiaofeng Hou
      • Xuzhou, Jiangsu, China, 221002
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
        • Principal Investigator:
          • Chengzong Li
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Zhiguo Zhang
          • Phone Number: +86 13504315927
          • Email: zg529@163.com
        • Principal Investigator:
          • Zhiguo Zhang
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Not yet recruiting
        • First Affiliated Hospital of Dalian Medical University
        • Contact:
        • Principal Investigator:
          • Rongfeng Zhang
      • Shenyang, Liaoning, China, 110004
        • Not yet recruiting
        • Shengjing Hospital Affiliated to China Medical University
        • Contact:
        • Principal Investigator:
          • Zhijun Sun
    • Shandong
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Peili Bu
      • Liaocheng, Shandong, China, 252000
        • Not yet recruiting
        • Liaocheng People's Hospital
        • Contact:
          • Degui Kong
          • Phone Number: +86 13563018096
          • Email: tydg@163.com
        • Principal Investigator:
          • Degui Kong
      • Liaocheng, Shandong, China, 252299
        • Not yet recruiting
        • Liaocheng Heart Hospital
        • Contact:
        • Principal Investigator:
          • Daling Zhang
    • Sichuan
      • Chengdu, Sichuan, China, 611130
        • Not yet recruiting
        • Chengdu Fifth People's Hospital
        • Contact:
        • Principal Investigator:
          • Mingjian Lang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contact:
        • Principal Investigator:
          • Xiaogang Guo
      • Hangzhou, Zhejiang, China, 310009
        • Not yet recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Principal Investigator:
          • Chenyang Jiang
        • Contact:
      • Ningbo, Zhejiang, China, 315000
        • Not yet recruiting
        • Ningbo No.2 Hospital
        • Contact:
        • Principal Investigator:
          • XianFeng Du

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Discontinuation of NOACs
Participants randomized to the experimental arm will stop oral anticoagulation (NOACs) immediately after randomization. All participants in this trial (including this arm) will undergo intensified rhythm surveillance using a smartwatch capable of single-lead ECG plus scheduled Holter or single-lead ECG patch monitoring (at least every 6 months; every 2 months encouraged), with symptom-triggered and opportunistic ECGs. AF recurrence is defined as ECG-documented AF/AFL/atrial tachycardia lasting ≥30 seconds.
Drug: NOAC discontinuation
Stop NOACs immediately after randomization (experimental arm)
Device: 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).
Active Comparator: Continuation of NOACs
Participants randomized to the control arm will continue NOAC therapy after randomization. The same intensified rhythm monitoring approach (smartwatch ECG plus scheduled Holter/patch and symptom/opportunistic ECG confirmation) applies.
Device: 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).
Drug: NOAC continuation
Continue guideline-recommended NOAC therapy after randomization (control arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite of all-cause death, ischemic stroke, or systemic embolism
Time Frame: 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).
48 months
ISTH major bleeding or ISTH clinically relevant non-major bleeding
Time Frame: 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).
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic embolism
Time Frame: 48 months
48 months
Cardiovascular death
Time Frame: 48 months
48 months
Major bleeding
Time Frame: 48 months
48 months
Clinically relevant non-major bleeding
Time Frame: 48 months

Clinically relevant non-major bleeding is defined as any sign or symptom of hemorrhage that does not meet the criteria for the ISTH definition of major bleeding, but meets at least one of the following criteria:

  1. Requiring medical intervention by a healthcare professional.
  2. Leading to hospitalization or increased level of care.
  3. Prompting a face-to-face evaluation by a healthcare provider.
48 months
Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT) score
Time Frame: 48 months
The AFEQT score ranges from 0 to 100, with higher scores indicating better QoL.
48 months
Five-Level EuroQol Five Dimensions Questionnaire (EQ-5D-5L) score
Time Frame: 48 months
The EQ-5D-5L measures health-related quality of life. It has two parts: 1) a 5-dimension descriptive system (mobility, self-care, usual activities, pain, anxiety/depression) with 5 levels per dimension, generating a utility value; 2) a Visual Analogue Scale (VAS) from 0 (worst) to 100 (best) for overall health. Higher scores indicate better health.
48 months
Generalized Anxiety Disorder-7 item questionnaire (GAD-7) score
Time Frame: 48 months
Anxiety is measured by GAD-7 score, with scores ranging from 0 to 21, where higher scores indicate greater levels of anxiety.
48 months
Patient Health Questionnaire-9 item questionnaire (PHQ-9) score
Time Frame: 48 months
Depression is evaluated using PHQ-9 score, which is scored from 0 to 27, with a higher score indicating greater levels of depression.
48 months
All-cause death
Time Frame: 48 months
48 months
Ischemic stroke
Time Frame: 48 months
48 months
Atrial fibrillation Recurrence
Time Frame: 48 months
Defined as atrial tachyarrhythmia lasting ≥30s on ECG
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Investigators

  • Principal Investigator: Changsheng Ma, MD, Beijing Anzhen Hospital
  • Principal Investigator: Caihua Sang, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025KLS09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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