Less invasive heart repair: device closure offers hope for children with VSD
NCT ID NCT07715032
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This study looks at how well a device can close a common heart hole called a ventricular septal defect (VSD) in children aged 6 months to 18 years. Instead of open-heart surgery, doctors use a small tube to place a device that plugs the hole. The goal is to see if this method is safe and works well, and to track any problems up to 6 months later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a device called an Amplatzer occluder (Ductal, Muscular, or Membranous VSD Occluder) used to close the hole in the heart
- What this could lead to
- If successful, this could confirm that closing heart holes with a device is a safe, effective alternative to open-heart surgery for children.
- What could go wrong
- This is a small, short-term study from two centers, so results may not apply broadly. Risks include residual leaks, heart rhythm problems, or device-related issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Paediatric patients (age ≤18 years) undergoing percutaneous device closure of VSDs at the participating centres
- Ages
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6 months to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: 6 months to 18 years 2. Confirmed diagnosis of VSD (perimembranous, muscular) by transthoracic echocardiography (TTE) 3. Hemodynamically significant VSD with: (Imtiaz et al., 2023) * Pulmonary blood flow (Qp) to Systemic blood flow (Qs) ≥1.5:1, OR * Evidence of left ventricular volume overload, OR * Pulmonary arterial hypertension (PAH) with reversible pulmonary vascular resistance 4. Suitable anatomy for device closure as assessed by TTE and/or transesophageal echocardiography (TEE) 5. Adequate rim (≥2mm) from VSD edges to cardiac valves and conduction system (for perimembranous VSDs) 6. Written informed consent from parents/legal guardians 7. Assent from children ≥ 12 years (as appropriate Exclusion Criteria: 1. Active endocarditis or systemic infection 2. Fixed, irreversible pulmonary arterial hypertension (pulmonary vascular resistance \>8 Wood units/m² or ratio of pulmonary vascular resistance (Rp) to systemic vascular resistance (Rs) \>0.5) 3. Multiple VSDs not amenable to device closure 4. VSD associated with complex congenital heart disease requiring surgical intervention 5. Contraindication to antiplatelet therapy 6. Known allergy to device materials (nickel-titanium alloy) 7. Patient or family unwilling to comply with follow-up protocol 8. Life expectancy \<1 year due to non-cardiac conditions 9. Body weight \<5 kg (relative contraindication, case-by-case assessment)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.