Evidence map›Paper›PMID 41698716›Full record

ArticleBMJ open2026

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).

Lan Shen, Lisheng Jiang, Ziyong Hao, Huimin Chu, Xinhua Wang, Zhongping Ning, Junfeng Zhang, Bin Yang, Yawei Xu, Renyuan Fang and 16 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Lan Shen *University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA dr.lan.a.shen@gmail.com heben241@126.com.ORCID http://orcid.org/0009-0003-6652-2709
Lisheng Jiang *Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Ziyong Hao *Department of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Huimin ChuDepartment of Cardiovascular Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China.
Xinhua WangDepartment of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Zhongping NingDepartment of Cardiology, Shanghai Pudong New District Zhoupu Hospital, Pudong, Shanghai, China.
Junfeng ZhangDepartment of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, Shanghai, China.
Bin YangDepartment of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Yawei XuDepartment of Cardiology, Shanghai Tenth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Renyuan FangDepartment of Cardiovascular Medicine, The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang, China.
Lingcong KongDepartment of Cardiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Xiaogang ZhangDepartment of Cardiology, Shanghai Pudong New District Zhoupu Hospital, Pudong, Shanghai, China.
Qing HeDepartment of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, Shanghai, China.
Zongqi ZhangDepartment of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, Shanghai, China.
Tiantian ZhangDepartment of Cardiology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, Shanghai, China.
Cen DuDepartment of Geriatrics, The Ninth People's Hospital Affiliated of Shanghai Jiaotong University, Shanghai, China.
Yizhang WuDepartment of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Dongdong ZhaoDepartment of Cardiology, Shanghai Tenth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Hengye HuangSchool of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Wenyan MaClinical Research Unit, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Zhao LiangDepartment of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Xin PanDepartment of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Cheng WangDepartment of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yutong MiaoDepartment of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID http://orcid.org/0000-0001-7556-3252
Linghong ShenDepartment of Cardiology, Shanghai Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Ben HeDepartment of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China dr.lan.a.shen@gmail.com heben241@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAtrial 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.

Indexed as

AnticoagulantsAtrial AppendageAtrial FibrillationCatheter AblationLeft Atrial Appendage ClosurePulmonary VeinsStrokeAdministration, OralEquivalence Trials as TopicHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicAnticoagulantsAnticoagulationCARDIOLOGYCoronary interventionPatients

Identifiers

PMID41698716
PMCPMC12911697

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.