What is the clinical evidence from this study?

Study design: RCT. Population: Atrial septal defect (n=112). Intervention: Pansy biodegradable ASD occluder vs. Traditional metal occluder. Primary outcome: Closure success rate at 6 months post-operation.

What question did this study set out to answer?

The aim is to evaluate the safety and effectiveness of the Pansy ASD occluder compared to metal occluders.

June 19, 2026Cardiovascular Intervention and Therapeutics0 citationsOpen Access

A scaffold-degradable single-rivet ASD occluder with amplatzer-like design: a multicenter randomized controlled trial

LZLiqing ZhaoShanghai Jiao Tong University JGJiawei GaoXinHua Hospital XZX L ZhouXinHua Hospital

Key Result

The biodegradable Pansy occluder achieved a 100% closure success rate at 6 months, demonstrating non-inferiority to traditional metal occluders in patients with atrial septal defects.

Key Points

The aim is to evaluate the safety and effectiveness of the Pansy ASD occluder compared to metal occluders.
Multicenter randomized controlled trial involving adult and pediatric patients.
112 patients received implantation of either the Pansy occluder or a metal occluder control.
Primary efficacy endpoint was the closure success rate at six months post-operation.
Closure success rate was 100% for both the Pansy and metal occluder groups at six months.
One patient in the experimental group required explantation due to abnormal tissue hyperplasia.
At 12 months post-operation, 109 patients maintained a 100% closure success rate in both groups.

Study Design

Type

RCT (n=112)

Randomization

1:1 ratio by center using a blocked randomization scheme

Multicenter

Yes

Structured PICO

Does a biodegradable Pansy ASD occluder maintain closure success rates compared to a metal occluder in adult and pediatric patients with ASD?

Population

112 adult and pediatric patients (aged ≥ 2 years) with secundum atrial septal defects were randomized to receive either a biodegradable or metallic occluder and followed for 12 months.

Intervention

Biodegradable Pansy ASD occluder with a polydioxanone (PDO) framework

Comparator

Metal ASD occluder

Outcome

Closure success rate at six months post-operationsurrogate

The novel biodegradable Pansy ASD occluder demonstrated a 100% closure success rate at 6 and 12 months, comparable to traditional metal occluders, with promising safety.

Main Result

Absolute Event Rate: 100% vs 100%

Limitations

Limited number of patients (n=112)
Did not include patients with complex ASD with poor rim conditions
Lack of radiopacity under DSA

Abstract

Metallic atrial septal defect (ASD) occluders are associated with various mid- to long-term complications. To address this, our team developed a novel biodegradable Pansy ASD occluder, and this multicenter RCT aimed to evaluate its effectiveness and safety. A prospective, multicenter, randomized controlled trial was carried out on adult and pediatric patients using the Pansy occluder with a biodegradable polydioxanone (PDO) framework. The primary efficacy endpoint of this clinical trial is the closure success rate at six months post-operation. From May 2021 to March 2023, a total of 127 patients were screened across seven research centers, with 112 patients (including 71 pediatric patients; 57 to the experimental group, 55 to the metal occluder control group) ultimately underwent occluder implantation. In these patients, the average defect size was 8.48 ± 2.86 mm in the experimental group and 10.41 ± 5.21 mm in the control group. The closure success rate at six months post-operation was 100% for both groups, and no residual shunt greater than 5 mm was detected at any follow-up time point. In the experimental group, one patient required device explantation at 10 months postoperatively due to abnormal tissue hyperplasia. Pathological analysis confirmed near-complete degradation of the PDO framework with smooth endothelial coverage. A total of 109 patients completed the 12-month post-operative follow-up, with both groups again demonstrating a closure success rate of 100%. The Pansy occluder shows promising safety and efficacy outcomes at 12 months, though longer-term data are needed to confirm durability.

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