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Atrial Fibrillation (AF)DIAMOND-AFNCT06871228

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

A study testing NOAC discontinuation, NOAC continuation and Smartwatch single-lead ECG monitoring in people with Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 22 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
NOAC discontinuation, NOAC continuation and Smartwatch single-lead ECG monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,100 participants
Where
22 sitesChina
Study dates
5 Aug 2025to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liu He, PhD contact

13810720787

theliu@139.com

Caihua Sang, MD contact

22 sites in 1 country

China22 sites, 22 recruiting

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 100029

    Liu He, +86 13810720787, theliu@139.com

    Changsheng Ma

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    Zhiguo Zhang, +86 13504315927, zg529@163.com

    Zhiguo Zhang

    Not yet recruiting

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan, 611130

    Mingjian Lang, +86 18200215569, lmjian1976@163.com

    Mingjian Lang

    Not yet recruiting

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

    Rongfeng Zhang, +86 18098875798, zrf0088@126.com

    Rongfeng Zhang

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Xianhong Fang, +86 13710608335, fangxianhong@gdph.org.cn

    Xianhong Fang

    Not yet recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Xiaogang Guo, +86 13867441856, gxg22222@zju.edu.cn

    Xiaogang Guo

    Not yet recruiting

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

    Hangzhou, Zhejiang, 310009

    Chenyang Jiang, +86 13857190051, jiangchenyangmail@163.com

    Chenyang Jiang

    Not yet recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Yue Li, +86 13945057313, ly99ly@vip.163.com

    Yue Li

    Not yet recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150085

    Bo Yu, +86 13804585601, yubodr@163.com

    Bo Yu

    Not yet recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Ronghui Yu, +86 13901080383, ronghuiyu@vip.sina.com

    Ronghui Yu

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Peili Bu, +86 18560086596, bupeili@medmail.com.cn

    Peili Bu

    Not yet recruiting

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

    Degui Kong, +86 13563018096, tydg@163.com

    Degui Kong

    Not yet recruiting

  • Liaocheng Heart Hospital

    Liaocheng, Shandong, 252299

    Daling Zhang, +86 13793093168, dl_zhang1119@163.com

    Daling Zhang

    Not yet recruiting

  • Luohe Central Hospital

    Luohe, Henan, 462003

    Jirui Cai, +86 15039500678, cjr272@126.com

    Jirui Cai

    Not yet recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210036

    Xiaofeng Hou, +86 13770609205, xfhou@njmu.edu.cn

    Xiaofeng Hou

    Not yet recruiting

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang, 315000

    Xianfeng Du, +86 13967851533, drduxianfeng@126.com

    Xianfeng Du

    Not yet recruiting

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110004

    Zhijun Sun, +86 18940251218, sunzj@sj-hospital.org

    Zhijun Sun

    Not yet recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Jinming Liu, +86 13833180891, liujinming74@163.com

    Jinming Liu

    Not yet recruiting

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022

    Hua Yan, +86 13100659066, yanhua0807@aliyun.com

    Hua Yan

    Not yet recruiting

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

    Wuhan, Hubei, 430030

    Yan Wang, +86 13697326307, newswangyan@126.com

    Yan Wang

    Not yet recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

    Chengzong Li, +86 13685116939, chengzong2008@163.com

    Chengzong Li

    Not yet recruiting

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan, 450003

    Yiqiang Yuan, +86 13838125038, xkyuanyq@zzu.edu.cn

    Yiqiang Yuan

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
NOAC discontinuation, NOAC continuation, Smartwatch single-lead ECG monitoring
Keywords
atrial fibrillation, catheter ablation, smartwatch, anticoagulation, thromboembolism, bleeding
Medical subject headings
Atrial Fibrillation, Thromboembolism, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NOAC discontinuationDrug

    Stop NOACs immediately after randomization (experimental arm)

  • NOAC continuationDrug

    Continue guideline-recommended NOAC therapy after randomization (control arm)

  • Smartwatch single-lead ECG monitoringDevice

    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 groups in NCT06871228
Study groupRoleWhat they receive
Discontinuation of NOACsExperimentalParticipants 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.
Receives: Drug: NOAC discontinuation; Device: Smartwatch single-lead ECG monitoring
Continuation of NOACsActive comparatorParticipants 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.
Receives: Drug: NOAC continuation; Device: Smartwatch single-lead ECG monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A composite of all-cause death, ischemic stroke, or systemic embolism

    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).

    Measured: 48 months

  2. ISTH major bleeding or ISTH clinically relevant non-major bleeding

    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).

    Measured: 48 months

Secondary outcomes (11)

  1. All-cause death

    Measured: 48 months

  2. Ischemic stroke

    Measured: 48 months

  3. Systemic embolism

    Measured: 48 months

  4. Major bleeding

    Measured: 48 months

  5. Clinically relevant non-major bleeding

    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.

    Measured: 48 months

  6. Cardiovascular death

    Measured: 48 months

  7. Atrial Fibrillation Effect on Quality-of-Life questionnaire (AFEQT) score

    The AFEQT score ranges from 0 to 100, with higher scores indicating better QoL.

    Measured: 48 months

  8. Atrial fibrillation Recurrence

    Defined as atrial tachyarrhythmia lasting ≥30s on ECG

    Measured: 48 months

  9. Five-Level EuroQol Five Dimensions Questionnaire (EQ-5D-5L) score

    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.

    Measured: 48 months

  10. Generalized Anxiety Disorder-7 item questionnaire (GAD-7) score

    Anxiety is measured by GAD-7 score, with scores ranging from 0 to 21, where higher scores indicate greater levels of anxiety.

    Measured: 48 months

  11. Patient Health Questionnaire-9 item questionnaire (PHQ-9) score

    Depression is evaluated using PHQ-9 score, which is scored from 0 to 27, with a higher score indicating greater levels of depression.

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start5 Aug 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06871228
Sponsor's protocol ID
2025KLS09
Acronym
DIAMOND-AF
Status last verified
Jan 2026
First submitted
26 Feb 2025
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NOAC discontinuation, NOAC continuation and Smartwatch single-lead ECG monitoring in people with Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 22 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liu He, PhD (13810720787, theliu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A composite of all-cause death, ischemic stroke, or systemic embolism (time frame: 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06871228.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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