Evidence map›Paper›PMID 41078120›Full record

Trial reportCirculation2026

Transcatheter Closure of Patent Foramen Ovale With a Novel Biodegradable Device: A Prospective, Multicenter, Randomized Controlled Clinical Trial.

Fengwen Zhang, Jie Dong, Peijian Wei, Weiyi Fang, Hao Hu, Xiangqing Kong, Ming Bai, Jiahua Pan, Zhiling Luo, Ping Zhang and 6 more

Erratum issuedAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Circulation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Bioresorbable patent foramen ovale closure-is less more?Cardiovascular diagnosis and therapy · 2026
    Article
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Fengwen Zhang *Department of Structural Heart Disease, Fuwai Hospital & National Center for Cardiovascular Disease, Key Laboratory of Innovative Cardiovascular Devices, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Beijing, China (F.Z., J.D., P.W., C.W., S.W., X.P.).
Jie Dong *Department of Structural Heart Disease, Fuwai Hospital & National Center for Cardiovascular Disease, Key Laboratory of Innovative Cardiovascular Devices, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Beijing, China (F.Z., J.D., P.W., C.W., S.W., X.P.).ORCID 0000-0002-7933-6214
Peijian Wei *Department of Structural Heart Disease, Fuwai Hospital & National Center for Cardiovascular Disease, Key Laboratory of Innovative Cardiovascular Devices, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Beijing, China (F.Z., J.D., P.W., C.W., S.W., X.P.).ORCID 0000-0002-2791-4000
Weiyi Fang *Department of Cardiology, Hefei High-Tech Cardiovascular Disease Hospital, China (W.F.).
Hao HuDepartment of Cardiology, The Second Hospital of Lanzhou University, China (H.H.).
Xiangqing KongDepartment of Cardiology, The First Affiliated Hospital with Nanjing Medical University, China (X.K.).ORCID 0000-0003-3309-1140
Ming BaiDepartment of Cardiology, The First Hospital of Lanzhou University, China (M.B.).
Jiahua PanDepartments of Cardiology (J.P., Z.L.), Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Affiliated Cardiovascular Hospital of Kunming Medical University, China.
Zhiling LuoDepartments of Cardiology (J.P., Z.L.), Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Affiliated Cardiovascular Hospital of Kunming Medical University, China.
Ping ZhangDepartment of Cardiology, Guizhou Provincial People's Hospital, Guiyang, China (P.Z.).
Baiming QuDepartment of Cardiology, Zhejiang Provincial People's Hospital, Hangzhou, China (B.Q.).
Jinpeng HuShanghai Shape Memory Alloy Ltd, China (J.H.).ORCID 0000-0002-6737-3974
Yaoxing LuFuwai Shenzhen Hospital, Chinese Academy of Medical Sciences, China (Y.L., X.P.).
Chuangshi WangDepartment of Structural Heart Disease, Fuwai Hospital & National Center for Cardiovascular Disease, Key Laboratory of Innovative Cardiovascular Devices, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Beijing, China (F.Z., J.D., P.W., C.W., S.W., X.P.).ORCID 0000-0002-8093-4553
Shouzheng WangDepartment of Structural Heart Disease, Fuwai Hospital & National Center for Cardiovascular Disease, Key Laboratory of Innovative Cardiovascular Devices, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Beijing, China (F.Z., J.D., P.W., C.W., S.W., X.P.).
Xiangbin PanDepartment of Structural Heart Disease, Fuwai Hospital & National Center for Cardiovascular Disease, Key Laboratory of Innovative Cardiovascular Devices, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Cardiovascular Diseases, Beijing, China (F.Z., J.D., P.W., C.W., S.W., X.P.).ORCID 0000-0002-7090-4414

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNovel biodegradable patent foramen ovale (PFO) closure devices offer a promising therapeutic option. The efficacy and safety of the novel biodegradable devices compared with nitinol devices have not yet been investigated in a randomized clinical trial.

methodsThis multicenter, randomized, noninferiority trial examined whether the novel biodegradable PFO closure device achieves comparable closure success rates as traditional nitinol devices while demonstrating disappearance of the protruding parts of the device on echocardiography. A total of 190 patients with PFO were enrolled and randomly assigned to receive either the biodegradable device (n=96) or the nitinol device (n=94). The primary efficacy end point was PFO closure success rate at 6 months postprocedure as demonstrated by contrast echocardiography. We continued to evaluate device-related complications, device disappearance on echocardiography, and closure success rates over a 24-month follow-up period.

resultsSuccessful PFO closure was achieved in 87 patients (90.63%) in the biodegradable device group and 86 patients (91.49%) in the nitinol device control group. The lower limit of the 95% CI of absolute difference was -8.98%, greater than the predefined noninferiority margin of -10%, confirming that the biodegradable device was not inferior to the nitinol device in terms of closure success. One patient in the trial group required surgical device removal because of intraprocedural deformation. No deaths, embolism, thrombus on the device, or erosion were observed in either group throughout the entire study period. Transthoracic echocardiography revealed that the hyperechoic area corresponding to the biodegradable device began decreasing within the first year after implantation and disappeared on echocardiography by 24 months after implantation.

conclusionsThe novel biodegradable PFO closure device, which disappears on echocardiography within 24 months after implantation, demonstrates noninferiority to the traditional nitinol device in both efficacy and safety.

Indexed as

Absorbable ImplantsCardiac CatheterizationForamen Ovale, PatentSeptal Occluder DeviceAdultAgedAlloysFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAlloysnitinolabsorbable implantsechocardiographyforamen ovale, patentrandomized controlled trial

Identifiers

PMID41078120

What OpenQuestion holds

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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.