Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

NCT07040579 | Not Yet Recruiting

• 1 other identifier: GXMU-VSDO-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.

Conditions

Congenital Heart Defects; VSD

Keywords

transcatheter; bioabsorbable occluder; outlet VSD

Outcome Measures

Primary Outcomes (1)

• Number of participants with procedural success

  1. Occluder in correct anatomical position 2. Absence of major adverse events (all-cause mortality, all stroke, myocardial infarction, or re-hospitalization for device/procedure-related causes) 3) Residual shunt ≤ 2 mm and aortic regurgitation ≤ trace evaluated by transthoracic or transesophageal echocardiography

  12 months

Secondary Outcomes (8)

• Number of participants with technical success

  Intraprocedural

• Number of participants with major adverse events

  12/24/60 months

• Closure Efficacy

  Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months

• Aortic regurgitation severity

  Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months

• Pulmonary regurgitation severity

  Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months

Study Arms (1)

BioOccl-VSD

Patients with outlet ventricular septal defects undergoing transcatheter closure with bioabsorbable occluders.

Device: transcatheter closure of outlet VSDs with bioabsorbable occluders

Interventions

transcatheter closure of outlet VSDs with bioabsorbable occluders DEVICE

Transcatheter closure of outlet ventricular septal defects using a bioabsorbable occluder (Shape Memory Alloy Ltd, Shanghai, China). Implantation is performed via femoral/transthoracic approach under echocardiographic guidance following standard interventional protocols.

BioOccl-VSD

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients diagnosed with outlet ventricular septal defects who undergo transcatheter closure with bioabsorbable occluders

You may qualify if:

• Age ≥1 year and weight ≥10 kg
• Outlet VSD without ventricular malalignment
• Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography
• Written informed consent

You may not qualify if:

• Outlet VSD with a fibrous postero-inferior rim
• Concurrent cardiac conditions requiring surgical correction
• Severe pulmonary hypertension (PVR \> 5 WU, assessed by right heart catheterization )
• Intracardiac thrombus
• Pregnancy
• Active systemic infection within 1 month

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Liuliu Huang, MD

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liuliu Huang, MD

CONTACT

+8618577780131; dochuangllgxnn@gmail.com

Ji Wu, MD

CONTACT

+8613978862109; gxnnwuji@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 27, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): September 30, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)