Evidence map›Paper›PMID 42046172›Full record

ArticleCardiovascular therapeutics2026

Safety and Feasibility of a Novel Split Design Left Atrial Appendage Occluder: From Preclinical Investigations to First-in-Human Application.

Mingfei Li, Dawei Lin, Lei Zhang, Yuan Zhang, Wenzhi Pan, Xiaochun Zhang, Daxin Zhou, Junbo Ge

Abstract read
In one paragraph

Article in Cardiovascular therapeutics, 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. Article
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

8 authors.

Mingfei LiDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China, zs-hospital.sh.cn.
Dawei LinDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China, zs-hospital.sh.cn.
Lei ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China, zs-hospital.sh.cn.
Yuan ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China, zs-hospital.sh.cn.
Wenzhi PanDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China, zs-hospital.sh.cn.
Xiaochun ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China, zs-hospital.sh.cn.ORCID https://orcid.org/0009-0005-9643-5416
Daxin ZhouDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China, zs-hospital.sh.cn.ORCID https://orcid.org/0009-0007-9814-3630
Junbo GeDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China, zs-hospital.sh.cn.ORCID https://orcid.org/0000-0002-9360-7332

Funding

Shanghai Clinical Research Center for Interventional Medicine 19MC1910300
6 · The paper itself

Abstract

objectiveThis study was designed to first evaluate the histological compatibility of the split occluder in preclinical animal models, followed by clinical validation of its procedural feasibility and occlusion effectiveness in a first-in-human trial cohort.

methodsEight healthy labrador retrievers were selected for this study. A split-type occluder was introduced to occlude their left atrial appendage. The experimental animals were euthanized at 1, 3, and 6 months, respectively. Prior to being euthanized, transesophageal echocardiogram (TEE) and pulmonary vein computed tomography venography (CTV) were conducted on the subjects. A gross anatomical examination was then conducted on each animal post euthanasia. Additionally, data from 12 patients who underwent LAAO procedures using this device were included in the study. Each patient was monitored over a 3-month follow-up period.

resultsThe operations to insert split left atrial appendage occluders into each of the eight test dogs were successful. Subsequent TEE and pulmonary vein CTV revealed that occluder surfaces exhibited no thrombus formation and that the occluders exhibited no significant residual flow. The gross anatomical examination indicated satisfactory endothelialization. The occluders were successfully implanted in all 12 patients, with no complications reported in the occlusions during the subsequent 3-month follow-up period.

conclusionsIn both animal and human studies, the split occluder demonstrated a significantly high immediate success rate in the occlusion of the left atrial appendage. This was accompanied by a low occurrence of residual shunts and device-related complications, indicating its reliability and efficacy.

Indexed as

Atrial AppendageAtrial FibrillationLeft Atrial Appendage ClosureSeptal Occluder DeviceAdultAgedAnimalsComputed Tomography AngiographyDogsEchocardiography, TransesophagealFeasibility StudiesFemaleHumansMaleMiddle AgedPhlebographyanimal experimentsatrial fibrillationleft atrial appendage occlusionthe split occluder

Identifiers

PMID42046172
PMCPMC13121088

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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.