NCT05371366

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Septal Defect

Interventions

Type	Name	Description
DEVICE	ASD closure with the novel occluder (ReAces)	Transcatheter closure atrial septal defect with the novel occluder (ReAces)
DEVICE	ASD closure with normal occluder	Transcatheter closure atrial septal defect with normal occluder

Timeline

• Start date: 2022-04-22
• Primary completion: 2023-04-22
• Completion: 2023-04-22
• First posted: 2022-05-12
• Last updated: 2022-05-24

Locations

1 site across 1 country: China