Evidence map›Paper›PMID 40306851›Full record

ArticleJACC. Basic to translational science2025

A Novel Patent Foramen Ovale Occluder With Left Clamp Arms: Preclinical Experiment and First-in-Human Study.

Shiqiang Hou, Peng Wang, Yuliang Long, Mingfei Li, Yuan Zhang, Lei Zhang, Xiaochun Zhang, Daxin Zhou, Wenzhi Pan, Junbo Ge

Abstract read
In one paragraph

Article in JACC. Basic to translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Shiqiang HouDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Peng WangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Yuliang LongDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Mingfei LiDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Yuan ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Lei ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Xiaochun ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Daxin ZhouDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China. Electronic address: 1194180219@qq.com.
Wenzhi PanDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China. Electronic address: peden@sina.com.
Junbo GeDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Traditional occluders for the closure of patent foramen ovale (PFO) may be associated with some potential risks, including device-related thrombus, induction of arrhythmias, residual shunt, and difficulty in puncturing atrial septum. The TriFlower device is a novel transcatheter PFO occluder that features a clamp arm design. The device success rate was 100% (n = 18) in the animal experiment. Endothelialization of the left clamp arms was completed at an early stage (30 days after implantation). The acute procedure success rate in 17 patients was 100%. At 6-month follow-up, the primary efficacy endpoint, an effective PFO closure defined as residual shunt grade 1 or lower, was met in 16 (94.1%) patients and 14 (82.4%) patients had a complete closure. There were no device-related complications. These findings indicate that the TriFlower device is feasible, safe, and effective for transcatheter PFO closure. Its potential advantages include rapid endothelialization and low left atrial interference.

Indexed as

endothelializationoccluderpatent foramen ovaletranscatheter closure

Identifiers

PMID40306851
PMCPMC12134604

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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.