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

NCT06871228 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4100

Last updated 2026-03-04

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)

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).

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • Changsheng Ma, MD · Beijing Anzhen Hospital

  • Caihua Sang · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06871228 on ClinicalTrials.gov