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NCT Number: NCT07040579

Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

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.

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Key information

Conditions

Congenital Heart Defects Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases VSD

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Outflow-type ventricular septal defects (outlet VSDs) represent a challenging subset of congenital heart defects due to their association with progressive aortic valve prolapse and regurgitation. While surgical repair remains the gold standard, no reliable occluder has been available for transcatheter closure of this defect subtype.

The anatomical proximity of outlet VSDs to the aortic valve has historically limited transcatheter interventions. Conventional eccentric metal occluders require strict patient selection, typically being feasible only in cases with small defects and minimal aortic valve prolapse. Moreover, long-term concerns persist regarding metal devices' impact on aortic valve function.

Bioabsorbable occluders have been clinically available for perimembranous VSD closure. Their soft material properties minimize mechanical trauma to the aortic valve, while gradual resorption over time may eliminate permanent device-related complications. However, robust data regarding their efficacy, safety, and long-term impact on aortic valve function in outlet VSDs remain lacking.

This study aims to evaluate the short- and long-term outcomes of bioabsorbable occluder closure in outlet VSD patients, with a focus on defect closure rates and aortic valve function preservation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Number of participants with procedural success

    Time frame: 12 months

    • Occluder in correct anatomical position
    • 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

Secondary outcomes

  1. Number of participants with technical success

    Time frame: Intraprocedural

    Absence of mortality, correct positioning of the occluder into the proper anatomical location， aortic regurgitation≤ trace by transthoracic or transesophageal echocardiography

  2. Number of participants with major adverse events

    Time frame: 12/24/60 months

    All-cause mortality, all stroke, myocardial infarction, re-hospitalization for device or procedure-related causes

  3. Closure Efficacy

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

    1）Successful closure: Rate of successful VSD closure (residual shunt ≤2 mm) assessed by transthoracic or transesophageal echocardiography.

    • Complete closure: Rate of complete closure (no residual shunt) assessed by transthoracic or transesophageal echocardiography.

  4. Aortic regurgitation severity

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

    Aortic regurgitation severity measured by transthoracic and/or transesophageal echocardiography. Assessment of aortic regurgitation severity according to current recommendations for valvular heart disease.

  5. Pulmonary regurgitation severity

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

    Pulmonary regurgitation severity measured by transthoracic and/or transesophageal echocardiography. Assessment of pulmonary regurgitation severity according to current recommendations for valvular heart disease.

  6. Left ventricular outflow tract (LVOT) velocity and pressure gradient

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

    Peak LVOT velocity (m/s) and maximum instantaneous pressure gradient (mmHg) measured by continuous-wave Doppler (CWD) echocardiography, using the simplified Bernoulli equation (ΔP = 4v²).

  7. Right ventricular outflow tract （RVOT）velocity and pressure gradient

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

    Peak LVOT velocity (m/s) and maximum instantaneous pressure gradient (mmHg) measured by continuous-wave Doppler (CWD) echocardiography, using the simplified Bernoulli equation (ΔP = 4v²).

  8. Disc area quantification

    Time frame: 72 hours post procedure, 1/3/6/12/24/60 months

    Left and right disc areas are measured by transthoracic echocardiography (TTE) planimetry in parasternal short-axis (PSAX), apical long-axis (ALAX), and apical 5-chamber (A5C) views using QLAB 3DQ Advanced software (Philips). The mean disc area is derived from the average of three orthogonal transthoracic echocardiography measurements.

Study contacts

Contact information is provided by the study sponsor or research team.

Ji Wu, MD

CONTACT

[email protected]

+8613978862109

Liuliu Huang, MD

CONTACT

[email protected]

+8618577780131

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Other

Registry information

Official study title

Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function

Acronym: ABSORB-VSD

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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