Trial reportBMC cardiovascular disorders2024
Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders.
Trial report in BMC cardiovascular disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05371366 (A Multicenter, Randomized, Parallel-controlled Clinical Trial to Evaluate the Efficacy and Safety of a New Atrial Septal Defect Occluder, ReAces®, and Delivery System for the Treatment of Atrial Septal Defect Occlusion), which is not on this map. Cited by 1 paper.
What it found
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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.
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.
A Multicenter, Randomized, Parallel-controlled Clinical Trial to Evaluate the Efficacy and Safety of a New Atrial Septal Defect Occluder, ReAces®, and Delivery System for the Treatment of Atrial Septal Defect Occlusion
Who cites it
1 citing paper in PubMed.
- Bioresorbable patent foramen ovale closure-is less more?Cardiovascular diagnosis and therapy · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundComplete endothelialization is often not achieved within 6 months after implantation of an atrial septal defect (ASD) occluder, which may lead to microthrombus or thrombosis. This study aimed to assess the endothelialization and morphology of a novel puncturable ASD occluder (ReAces) compared with traditional occluders 1 year post-implantation using computed tomography angiography (CTA).
methodsFifteen patients from each group in a randomized controlled trial comparing ReAces with traditional occluders were included at the 1-year follow-up at Zhongshan Hospital, Fudan University. Baseline characteristics and procedural data were recorded. CTA was performed to assess the device morphology and degree of endothelialization. Independent samples t-test and Fisher's exact test were primarily used to compare the above data.
resultsEach patient received a single device and had no residual shunts. There were no differences in defect size (15.3 ± 4.0 mm vs. 15.3 ± 4.7 mm, p = 1.00) or occluder size (21.2 ± 4.4 mm vs. 21.5 ± 5.3 mm, p = 0.882) between the two groups. At the 1-year follow-up CTA, the central region thickness (4.2 mm ± 0.9 mm vs. 7.8 mm ± 2.4 mm, p < 0.0001), left atrial device-occupied volume (1863.3 mm
conclusionsCompared with traditional occluders, ReAces presented a significantly greater complete endothelialization rate, lower central region thickness, lower left atrial device-occupied volume, and lower device compression rates at 1 year post-implantation by CTA.
trial registrationTrial registry: ClinicalTrials.gov. Unique identifying number: NCT05371366. Date of registration: 04/05/2022.
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