Phase
Condition
Dysrhythmia
Hemorrhage
Atrial Fibrillation
Treatment
PPG/ECG dual mode based smartwatch
Continuous DOAC therapy
Smartwatch single-lead ECG monitoring
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Participants must meet all of the following criteria:
Age 18 to 80 years.
60±15 to 365±15 days after atrial fibrillation/atrial flutter (AF/AFL) ablation.
CHA2DS2-VA score ≥2.
No history of stroke, transient ischemic attack (TIA), or systemic embolism.
Continuous use of a NOAC since AF/AFL ablation.
No documented atrial tachyarrhythmia recurrence since ablation.
No antiarrhythmic drug (AAD) use within the past 2 months.
Able and willing to provide written informed consent.
Able and willing to comply with study procedures and follow-up.
Exclusion Criteria
Participants will be excluded if any of the following criteria are present:
High risk of post-ablation recurrence (e.g. including premature atrial contraction burden >3% on any ambulatory ECG/Holter recording).
Moderate-to-severe mitral stenosis (mitral valve area ≤2.0 cm²) or mechanical heart valve.
Increased bleeding risk, including any of the following:
Current ISTH major bleeding or clinically relevant non-major bleeding (CRNMB).
History of non-traumatic major bleeding (e.g., intracranial, intraocular, spinal, retroperitoneal, gastrointestinal, or intra-articular) unless the reversible cause has been permanently 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 diathesis (e.g., hemophilia).
Uncontrolled hypertension (SBP >180 mmHg and/or DBP >110 mmHg).
Hemoglobin <90 g/L or blood transfusion within 4 weeks prior to enrollment.
Platelet count <50 × 10⁹/L.
End-stage kidney disease (eGFR <15 mL/min/1.73 m²) or on dialysis.
Severe liver disease (e.g., esophageal variceal bleeding, ascites, hepatic encephalopathy, or jaundice).
Known intolerance to oral anticoagulants or contraindication to oral anticoagulation.
Any condition requiring continued oral anticoagulation (e.g., pulmonary embolism, deep vein thrombosis, hypertrophic cardiomyopathy, cardiac amyloidosis).
Conditions associated with high non-cardioembolic stroke risk, including carotid, vertebral, or intracranial arterial stenosis ≥70%.
Prior left atrial appendage (LAA) occlusion, surgical LAA excision/closure, or intraoperative confirmation of LAA electrical isolation.
Female participants who are pregnant or breastfeeding, or of childbearing potential not using effective contraception.
Life expectancy <2 years.
Current participation in another interventional clinical trial.
Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230022
ChinaSite Not Available
The First Affiliated Hospital of Anhui Medical University
Hefei 1808722, Anhui 1818058 230022
ChinaSite Not Available
Beijing Anzhen Hospital
Beijing, Beijing Municipality 100029
ChinaActive - Recruiting
Beijing Anzhen Hospital
Beijing 1816670, Beijing Municipality 2038349 100029
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei 050000
ChinaSite Not Available
The Second Hospital of Hebei Medical University
Shijiazhuang 1795270, Hebei 1808773 050000
ChinaSite Not Available
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150001
ChinaSite Not Available
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150085
ChinaSite Not Available
The First Affiliated Hospital of Harbin Medical University
Harbin 2037013, Heilongjiang 2036965 150001
ChinaSite Not Available
The Second Affiliated Hospital of Harbin Medical University
Harbin 2037013, Heilongjiang 2036965 150085
ChinaSite Not Available
Luohe Central Hospital
Luohe, Henan 462003
ChinaSite Not Available
Henan Provincial Chest Hospital
Zhengzhou, Henan 450003
ChinaSite Not Available
Luohe Central Hospital
Luohe 1801934, Henan 1808520 462003
ChinaSite Not Available
Henan Provincial Chest Hospital
Zhengzhou 1784658, Henan 1808520 450003
ChinaSite Not Available
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaSite Not Available
Wuhan Asia Heart Hospital
Wuhan, Hubei 430022
ChinaSite Not Available
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan 1791247, Hubei 1806949 430030
ChinaSite Not Available
Wuhan Asia Heart Hospital
Wuhan 1791247, Hubei 1806949 430022
ChinaSite Not Available
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu 210036
ChinaSite Not Available
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221002
ChinaSite Not Available
The First Affiliated Hospital of Nanjing Medical University
Nanjing 1799962, Jiangsu 1806260 210036
ChinaSite Not Available
The Affiliated Hospital of Xuzhou Medical University
Xuzhou 10630003, Jiangsu 1806260 221002
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
The First Hospital of Jilin University
Changchun 2038180, Jilin 2036500 130021
ChinaSite Not Available
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning 116023
ChinaSite Not Available
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning 110004
ChinaSite Not Available
First Affiliated Hospital of Dalian Medical University
Dalian 1814087, Liaoning 2036115 116023
ChinaSite Not Available
Shengjing Hospital Affiliated to China Medical University
Shenyang 2034937, Liaoning 2036115 110004
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan, Shandong 250012
ChinaSite Not Available
Liaocheng Heart Hospital
Liaocheng, Shandong 252299
ChinaSite Not Available
Liaocheng People's Hospital
Liaocheng, Shandong 252000
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan 1805753, Shandong 1796328 250012
ChinaSite Not Available
Liaocheng Heart Hospital
Liaocheng 1803834, Shandong 1796328 252299
ChinaSite Not Available
Liaocheng People's Hospital
Liaocheng 1803834, Shandong 1796328 252000
ChinaSite Not Available
Chengdu Fifth People's Hospital
Chengdu, Sichuan 611130
ChinaSite Not Available
Chengdu Fifth People's Hospital
Chengdu 1815286, Sichuan 1794299 611130
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaSite Not Available
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310000
ChinaSite Not Available
Ningbo No.2 Hospital
Ningbo, Zhejiang 315000
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764 310009
ChinaSite Not Available

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