DIscontinuation of Anticoagulation MONitoreD by Smartwatch Versus Continuous Anticoagulation in Post-ablation Patients With Atrial Fibrillation: A Randomized Controlled Trial

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The DIAMOND-AF trial, an investigator-initiated multicenter study, randomizes 5,694 stroke-free AF patients with a CHA₂DS₂-VA score of 2-6 post-successful ablation to either smartwatch-guided intermittent direct oral anticoagulant (DOAC) therapy (30-day treatment triggered by AF episodes ≥1 hour single or ≥2 hours/24h) or continuous DOAC therapy. The trial assesses the superiority of intermittent DOAC therapy in reducing major bleeding (ISTH) compared to continuous DOAC therapy, and the non-inferiority of intermittent DOAC in preventing thromboembolism (stroke, embolism, and cardiovascular death) over a 48-month follow-up, aiming to tailor anticoagulation strategies in patients with rhythm control achieved through ablation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80 years.

• No recurrence of atrial arrhythmia within 3 months after the most recent AF/atrial flutter catheter ablation.

• CHA₂DS₂-VA score of 2-6.

• Voluntarily sign informed consent to participate in the study.

• Willingness and ability to comply with the study protocol.

Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Chengdu Fifth People's Hospital
NOT_YET_RECRUITING
Chengdu
First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Liaocheng People's Hospital
NOT_YET_RECRUITING
Liaocheng
Luohe Central Hospital
NOT_YET_RECRUITING
Luohe
The First Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Shengjing Hospital Affiliated to China Medical University
NOT_YET_RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Henan Provincial Chest Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Liu He, PhD
theliu@139.com
13810720787
Backup
Caihua Sang, MD
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 5694
Treatments
Experimental: Smart Watch-Guided Intermittent DOAC
Participants randomized to the intervention arm will be provided with a PPG-based smartwatch that continuously monitors their rhythm and an app to remind wearing the watch for at least 12 hours per day and taking DOAC on time, and follow-up. If AF is suspected based on the PPG data, the smartwatch will notify the participant to take an ECG. Both the participant and the coordinating center will be notified if a threshold AF event occurs.
Active_comparator: Continuous DOAC Therapy
Participants randomized to the control arm will remain on previously prescribed DOAC therapy, in line with current clinical practice. These participants will continue taking DOAC throughout the study as prescribed by their physicians unless contraindicated. They will also use the app for reminders regarding DOAC use and follow-up but will not receive the smartwatch.
Related Therapeutic Areas
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov