Actively Recruiting
Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation
Led by Beijing Anzhen Hospital · Updated on 2026-03-04
4100
Participants Needed
22
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- 607 to 3657 days after atrial fibrillation or atrial flutter ablation
- CHA2DS2-VA score of 2 or higher
- No history of stroke, transient ischemic attack, or systemic embolism
- Continuous use of a non-vitamin K antagonist oral anticoagulant (NOAC) since ablation
- No documented recurrence of atrial tachyarrhythmia since ablation
- No use of antiarrhythmic drugs in the past 2 months
- Able and willing to provide written informed consent
- Able and willing to comply with study procedures and follow-up
You will not qualify if you...
- High risk of atrial tachyarrhythmia recurrence (e.g., premature atrial contraction burden greater than 3% on ambulatory ECG/Holter)
- Moderate to severe mitral stenosis or mechanical heart valve
- Current major or clinically relevant non-major bleeding
- History of non-traumatic major bleeding unless the cause has been 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 disorders (e.g., hemophilia)
- Uncontrolled high blood pressure (systolic >180 mmHg or diastolic >110 mmHg)
- Low hemoglobin (<90 g/L) or blood transfusion within 4 weeks prior
- Low platelet count (<50 x 10^9/L)
- End-stage kidney disease or dialysis
- Severe liver disease
- Known intolerance or contraindication to oral anticoagulants
- Conditions requiring ongoing oral anticoagulation
- Conditions with high non-cardioembolic stroke risk (arterial stenosis 70%)
- Prior left atrial appendage occlusion or surgical closure
- Pregnant or breastfeeding females, or those of childbearing potential not using effective contraception
- Life expectancy less than 2 years
- Current participation in another interventional clinical trial
- Any condition making participation unsuitable in investigator's judgment
AI-Screening
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Trial Site Locations
Total: 22 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Not Yet Recruiting
2
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
4
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
5
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Not Yet Recruiting
6
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150085
Not Yet Recruiting
7
Luohe Central Hospital
Luohe, Henan, China, 462003
Not Yet Recruiting
8
Henan Provincial Chest Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
9
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Not Yet Recruiting
10
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Not Yet Recruiting
11
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210036
Not Yet Recruiting
12
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221002
Not Yet Recruiting
13
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
14
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116023
Not Yet Recruiting
15
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
16
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
17
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252000
Not Yet Recruiting
18
Liaocheng Heart Hospital
Liaocheng, Shandong, China, 252299
Not Yet Recruiting
19
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China, 611130
Not Yet Recruiting
20
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
21
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
22
Ningbo No.2 Hospital
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
Research Team
L
Liu He, PhD
CONTACT
C
Caihua Sang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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