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RECRUITING
NCT06871228
NA

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

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

4100

Start Date

2025-08-05

Completion Date

2029-12-31

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

NOAC discontinuation

Stop NOACs immediately after randomization (experimental arm)

DRUG

NOAC continuation

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

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