New Needle-Based heart treatment could help children with Drug-Resistant heart disease
NCT ID NCT06540183
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study tests a new, less invasive procedure called PIMSRA for children with obstructive hypertrophic cardiomyopathy, a condition where the heart muscle is too thick and blocks blood flow. The procedure uses a needle guided by ultrasound to deliver radiofrequency energy to the thickened part of the heart wall, aiming to reduce the blockage. Researchers are checking if it is safe and effective for children under 18 who have not improved with medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a minimally invasive procedure called percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) that uses a needle to deliver radiofrequency energy to the thickened heart muscle
- What this could lead to
- If successful, this procedure could offer a less invasive treatment option for children with obstructive hypertrophic cardiomyopathy who do not respond to medication.
- What could go wrong
- This is an early feasibility study with a small number of participants, so results may not apply to all children. Risks include serious complications like heart failure, abnormal heart rhythms, or need for emergency surgery.
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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23 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Dec 2025
- 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
Children with obstructive HCM who remain severely symptomatic despite medical therapy with LVOT obstruction (peak gradient ≥ 50mmHg) underwent percutaneous intramyocardial septal radiofrequency ablation from September 1, 2020 to April 30, 2024. A total of 23 consecutive children younger than 18 were included.
- Ages
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Up 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: * Clinical diagnosis of hypertrophic obstructive cardiomyopathy * Age younger than 18 years * Resting or provoking left ventricular outflow tract gradient ≥ 50 mmHg * Drug-refractory symptoms or intolerable to pharmaceutical therapies * Heart function of New York Heart Association ≥ class II Exclusion Criteria: * Secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis * Presence of concomitant heart disease requiring surgery * Left ventricular ejection fraction \<40% * Cardiac resynchronization therapy within 3 months
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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.
Contacts and locations
Locations
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Xijing Hospital
Xi'an, Shaanxi, 710032, China
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