{
  "abstract": "Introduction Atrial fibrillation (AF), with a prevalence of 1–2%, is the most common cardiac arrhythmia. AF is associated with a fivefold increased risk of cardioembolic events; approximately 20% of all strokes are caused by AF. Pulmonary vein isolation (PVI) has become the first-line treatment for AF. However, PVI cannot eliminate the residual stroke risk. Current guidelines recommend that anticoagulation be continued in this specific group of patients, regardless of the presence or absence of AF. In this large AF population post-PVI, who are considered to be in an earlier stage of AF, it is unknown whether left atrial appendage closure (LAAC) offers an alternative to direct oral anticoagulant (DOAC) therapy.Methods and analysis The trial will be a prospective, randomised, multicentre non-inferiority study comparing two treatment strategies in AF patients after atrial ablation. Patients will be randomly assigned to either percutaneous LAAC (group A) or DOAC treatment (group B) in a 1:1 ratio; both sequential and concomitant planned ablation with or without LAAC are accepted. Randomisation will be conducted using web-based randomisation software. A total of 1012 participants (506 patients per group) will be enrolled. The primary effectiveness measure will be the occurrence of any of the specified events within 24 months after randomisation: stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality and all-cause mortality.Ethics and dissemination The study was approved by the Ethical Review Board of Shanghai Chest Hospital, China (KS(Y)20287). Written informed consent will be obtained from all participants. The trial will follow the Declaration of Helsinki and Good Clinical Practice. Confidentiality will be maintained with anonymised, securely stored data. Findings will be disseminated through peer-reviewed publications and conferences.Trial registration number ChiCTR2000036538.",
  "authors": [
    {
      "affiliations": [
        "University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA"
      ],
      "name": "Lan Shen"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China"
      ],
      "name": "Lisheng Jiang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Ziyong Hao"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China"
      ],
      "name": "Huimin Chu"
    },
    {
      "affiliations": [
        "Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China"
      ],
      "name": "Xinhua Wang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Pudong New District Zhoupu Hospital, Pudong, Shanghai, China"
      ],
      "name": "Zhongping Ning"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China"
      ],
      "name": "Junfeng Zhang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China"
      ],
      "name": "Bin Yang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Tenth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China"
      ],
      "name": "Yawei Xu"
    },
    {
      "affiliations": [
        "Department of Cardiovascular Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China"
      ],
      "name": "Renyuan Fang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China"
      ],
      "name": "Lingcong Kong"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Pudong New District Zhoupu Hospital, Pudong, Shanghai, China"
      ],
      "name": "Xiaogang Zhang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China"
      ],
      "name": "Qing He"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China"
      ],
      "name": "Zongqi Zhang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital, Shanghai, China"
      ],
      "name": "Tiantian Zhang"
    },
    {
      "affiliations": [
        "Department of Geriatrics, The Ninth People's Hospital Affiliated of Shanghai Jiaotong University, Shanghai, China"
      ],
      "name": "Cen Du"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China"
      ],
      "name": "Yizhang Wu"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Tenth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China"
      ],
      "name": "Dongdong Zhao"
    },
    {
      "affiliations": [
        "School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Hengye Huang"
    },
    {
      "affiliations": [
        "Clinical Research Unit, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Wenyan Ma"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Zhao Liang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Xin Pan"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Cheng Wang"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Yutong Miao"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China"
      ],
      "name": "Linghong Shen"
    },
    {
      "affiliations": [
        "Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China"
      ],
      "name": "Ben He"
    }
  ],
  "title": "Left atrial appendage closure versus direct oral anticoagulants after pulmonary vein isolation for atrial fibrillation: protocol for a multicentre, prospective, randomised, non-inferiority trial (PROMOTE study)",
  "uid": "97ad7e78-6ef0-5d29-bfa4-ef24df12f056"
}