RecruitingNot ApplicableNCT06871228

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

DIscontinuation of Anticoagulation With Intensive Rhythm MONitoring CompareD With Continuous Anticoagulation in Post-ablation Patients With Atrial Fibrillation: A Randomized Controlled Trial

Sponsor

Beijing Anzhen Hospital

Enrollment

4,100 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether people who had a successful atrial fibrillation ablation procedure can safely stop taking blood thinners, guided by continuous heart rhythm monitoring with a wearable device. **You may be eligible if...** - You are between 18 and 80 years old - You had AF or atrial flutter ablation 60 to 365 days ago - Your stroke risk score (CHA2DS2-VA) is 2 or higher - You have had no recurrence of irregular heart rhythms since ablation - You have been continuously taking a NOAC blood thinner since ablation - You have no history of stroke, TIA, or systemic embolism **You may NOT be eligible if...** - You have a high risk of AF returning after ablation - You have significant mitral valve disease or a mechanical heart valve - You have an increased bleeding risk (recent major bleeding, unresolved ulcers, uncontrolled bleeding disorder) - You had major surgery recently or are planning surgery in the next 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNOAC discontinuation

Stop NOACs immediately after randomization (experimental arm)

DRUGNOAC continuation

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

DEVICESmartwatch 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).

Locations(22)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Luohe Central Hospital

Luohe, Henan, China

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

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

Wuhan, Hubei, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Liaocheng Heart Hospital

Liaocheng, Shandong, China

Chengdu Fifth People's Hospital

Chengdu, Sichuan, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06871228

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