Who is sponsoring NCT05371366?

NCT05371366 is sponsored by Shanghai Zhongshan Hospital.

What drugs are being tested in NCT05371366?

Interventions in NCT05371366: ASD closure with the novel occluder (ReAces), ASD closure with normal occluder.

What condition does NCT05371366 study?

NCT05371366 studies Atrial Septal Defect.

Is NCT05371366 still recruiting?

NCT05371366 is currently status unknown. Last updated 24 May 2022.

Last reviewed 2022-05-24 · How we verify

NCT05371366

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Puncturable Atrial Septal Defect Occluder Trial (the PASSER Trial)

Status unknown NA Last updated 24 May 2022

What this trial tests

NA trial testing ASD closure with the novel occluder (ReAces) in Atrial Septal Defect in 128 participants. Status unknown.

Timeline

22 April 2022

Primary endpoint
22 April 2023

22 April 2023

Quick facts

Lead sponsor	Shanghai Zhongshan Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	128
Start date	22 April 2022
Primary completion	22 April 2023
Estimated completion	22 April 2023
Sites	1 location across China

Drugs / interventions tested

ASD closure with the novel occluder (ReAces)
ASD closure with normal occluder

Conditions studied

Atrial Septal Defect — all drugs for Atrial Septal Defect →

Sponsor

Shanghai Zhongshan Hospital

Who can join

Adults 18 to 70, any sex, with Atrial Septal Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Compared with the traditional atrial septal occluder, this new atrial septal occluder supports re-puncture after occluder implantation. Thus those patients who have undergone atrial septal defect closure with the novel device may be eligible for future radiofrequency ablation of atrial fibrillation or mitral valve intervention. The trial is expected to enroll 128 patients who will be randomly assigned to the test group or control group in a 1:1 ratio. Patients in test group will received ReAces occluder，and the others the regular occluder.The experiment is scheduled to enroll 128 patients who will be randomly allocated to one of two groups: test or control. Patients in the test group will receive a ReAces occluder, while those in the control group will receive a standard occluder.The safety and efficacy of the two groups at 1 year after surgery will be compared.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

The molecular mechanisms of cardiac development and related diseases.
Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8
A Novel Puncturable Atrial Septal Defect Occluder: The Results of Preclinical Experiment and First-in-Human Study.
Zhang X, Chen S, Li W, Jilaihawi H, et al · · 2022 · cited 6× · PMID 36644281 · DOI 10.1016/j.jacbts.2022.06.010
Advances in preclinical surgical therapy of cardiovascular diseases.
Li P, Chang Y, Song J. · · 2024 · cited 3× · PMID 38701509 · DOI 10.1097/js9.0000000000001534
Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders.
Fang Y, Hou K, Lin D, Zhou D, et al · · 2024 · PMID 39734195 · DOI 10.1186/s12872-024-04438-1
Atrial Septal Defect Closure With the ReAces Device: Burning No Bridges.
Alkhouli M. · · 2022 · PMID 36644278 · DOI 10.1016/j.jacbts.2022.07.010

Verify or expand the search:

Other recruiting trials for Atrial Septal Defect

Currently open trials in the same condition.

NCT06849635 — Cera™ ASD Occluder Post-Market Clinical Follow-Up Study · recruiting
NCT06347276 — Cerebral Microembolization Associated With PFO Closure · recruiting

Other Shanghai Zhongshan Hospital trials

Trials by the same sponsor.

NCT07353476 — Radiotherapy Plus Anti-PD-1 Versus Anti-PD-1 Alone in ypTanyN⁺M0 NSCLC · Phase 2 · not yet recruiting
NCT07508956 — Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric · Phase 3 · not yet recruiting
NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
NCT07531368 — BBAP With CS Mapping Guidance · NA · not yet recruiting
NCT07501104 — Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05371366 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
Last refreshed: 24 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05371366.

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