Hypertrophic Cardiomyopathy, ObstructiveNCT06540183
Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children
An observational study of Hypertrophic Cardiomyopathy, Obstructive, run by Xijing Hospital at 1 site in China.
Trial summary
The primary purpose of this study was to demonstrate the safety and efficacy of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) in children and assessed its performance and functional outcomes in the follow-up. This is a single-arm, single-center study. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Obstructive
- What is being tested?
- Percutaneous intramyocardial septal radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Intramyocardial Septal Radiofrequency Ablation for Drug-refractory Obstructive Hypertrophic Cardiomyopathy in Children and Adolescents: An Early Feasibility Study
The primary purpose of this study was to demonstrate the safety and efficacy of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) in children and assessed its performance and functional outcomes in the follow-up. This is a single-arm, single-center study.
Read the detailed description
The prevalence of hypertrophic cardiomyopathy (HCM) ranks second among cardiomyopathies in children. The prognosis of HCM has been previously demonstrated to be closely correlated with age. HCM in childhood is frequently associated with severe symptoms and high mortality rates, exhibiting a 36% higher incidence of malignant ventricular arrhythmias compared to adults, and being twice as likely to necessitate advanced heart failure therapies such as heart transplantation or left heart assist devices. Surgical septal myectomy can effectively help patients with drug-refractory symptoms but carries risks inherent to invasive procedures and requires expertise that is not universally available. Alcohol septal ablation is not recommended for applications in the young patient group.
Percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) is a new method for the treatment of HCM using a special diagnosis and treatment device on the target area of the heart under the guidance of echocardiography. The method breaks through the worldwide problem of minimally invasive treatment of the myocardium on the beating heart, thus avoiding X-ray radiation and contrast agent damage. Previous research has illustrated the effectiveness and safety of PIMSRA for adult patients with obstructive HCM. We have found that PIMSRA results in sustained improvement in exercise capacity, persistent reduction in left ventricle outflow tract (LVOT) gradient, and sustained improvement in cardiac function.
This is an early feasibility study to evaluate the clinical safety and efficacy of PIMSRA in pediatric patients, as well as to assess postoperative cardiac function and exercise capacity.
- Conditions
- Hypertrophic Cardiomyopathy, Obstructive
- Being tested
- Percutaneous intramyocardial septal radiofrequency ablation
- Keywords
- Percutaneous Intramyocardial Septal Radiofrequency Ablation, children, hypertrophic cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous intramyocardial septal radiofrequency ablationProcedure or surgery
Percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) is an innovative minimally invasive ablation treatment. Under the real-time transthoracic echocardiography guidance, a radiofrequency electrode needle is introduced into the hypertrophied interventricular septum via the percutaneous intramyocardial approach. Then the needle tip is pushed to the target region of the interventricular septal (IVS) basal segment 8 to 10 mm from the subaortic valve. The main objective of PIMSRA is to reduce ventricular septal hypertrophy and left ventricular outflow tract obstruction by means of thermal ablation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety composite outcome
The number of people who reach the composite safety outcome (the occurrence of at least one) of the following measured variables: 1) all-cause death; 2) heart failure; 3) ventricular fibrillation.
Measured: 30 days
Feasibility outcome
The proportion of patients with a peak left ventricle outflow tract gradient lower than 30 mmHg.
Measured: 6 months
Secondary outcomes (4)
Major surgery-related adverse events
Emergency surgery, severe pericardial tamponade, conduction block due to deviation in ablation range, surgery related ventricular septal perforation, stroke and malignant arrhythmias.
Measured: 30 days
LVOT gradient
Left ventricular outflow tract gradient as measured by echocardiography.
Measured: through study completion, an average of 2 years
Maximum interventricular septal thickness
Maximum septal thickness as measured by echocardiography.
Measured: through study completion, an average of 2 years
New York Heart Association functional scale
New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2020
- Primary completion1 Nov 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Cardiomyopathy, ObstructiveStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liwen Liu, Ph.D, M.D., Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540183
- Sponsor's protocol ID
- KY20232356
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu L, Li J, Zuo L, Zhang J, Zhou M, Xu B, Hahn RT, Leon MB, Hsi DH, Ge J, Zhou X, Zhang J, Ge S, Xiong L. Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy. J Am Coll Cardiol. 2018 Oct 16;72(16):1898-1909. doi: 10.1016/j.jacc.2018.07.080.
PubMed 30309466Zhou M, Ta S, Hahn RT, Hsi DH, Leon MB, Hu R, Zhang J, Zuo L, Li J, Wang J, Wang B, Zhu X, Liu J, Han Y, Li X, Xu B, Zhang L, Hou L, Han C, Liu J, Liu L. Percutaneous Intramyocardial Septal Radiofrequency Ablation in Patients With Drug-Refractory Hypertrophic Obstructive Cardiomyopathy. JAMA Cardiol. 2022 May 1;7(5):529-538. doi: 10.1001/jamacardio.2022.0259.
PubMed 35353129
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Intramyocardial Septal Radiofrequency Ablation for Drug-refractory Obstructive Hypertrophic Cardiomyopathy in Children and Adolescents: An Early Feasibility Study
- ClinicalTrials.gov ID
- NCT06540183
- Acronym / sponsor ID
- KY20232356
- Conditions
- Hypertrophic Cardiomyopathy, Obstructive
- Keywords
- Percutaneous Intramyocardial Septal Radiofrequency Ablation, children, hypertrophic cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study was to demonstrate the safety and efficacy of percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) in children and assessed its performance and functional outcomes in the follow-up. This is a single-arm, single-center study.
Detailed description
The prevalence of hypertrophic cardiomyopathy (HCM) ranks second among cardiomyopathies in children. The prognosis of HCM has been previously demonstrated to be closely correlated with age. HCM in childhood is frequently associated with severe symptoms and high mortality rates, exhibiting a 36% higher incidence of malignant ventricular arrhythmias compared to adults, and being twice as likely to necessitate advanced heart failure therapies such as heart transplantation or left heart assist devices. Surgical septal myectomy can effectively help patients with drug-refractory symptoms but carries risks inherent to invasive procedures and requires expertise that is not universally available. Alcohol septal ablation is not recommended for applications in the young patient group.
Percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) is a new method for the treatment of HCM using a special diagnosis and treatment device on the target area of the heart under the guidance of echocardiography. The method breaks through the worldwide problem of minimally invasive treatment of the myocardium on the beating heart, thus avoiding X-ray radiation and contrast agent damage. Previous research has illustrated the effectiveness and safety of PIMSRA for adult patients with obstructive HCM. We have found that PIMSRA results in sustained improvement in exercise capacity, persistent reduction in left ventricle outflow tract (LVOT) gradient, and sustained improvement in cardiac function.
This is an early feasibility study to evaluate the clinical safety and efficacy of PIMSRA in pediatric patients, as well as to assess postoperative cardiac function and exercise capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous intramyocardial septal radiofrequency ablationPercutaneous intramyocardial septal radiofrequency ablation (PIMSRA) is an innovative minimally invasive ablation treatment. Under the real-time transthoracic echocardiography guidance, a radiofrequency electrode needle is introduced into the hypertrophied interventricular septum via the percutaneous intramyocardial approach. Then the needle tip is pushed to the target region of the interventricular septal (IVS) basal segment 8 to 10 mm from the subaortic valve. The main objective of PIMSRA is to reduce ventricular septal hypertrophy and left ventricular outflow tract obstruction by means of thermal ablation. | Procedure or surgery | – |
Primary outcome
Safety composite outcome
Time frame: 30 days
The number of people who reach the composite safety outcome (the occurrence of at least one) of the following measured variables: 1) all-cause death; 2) heart failure; 3) ventricular fibrillation.
Feasibility outcome
Time frame: 6 months
The proportion of patients with a peak left ventricle outflow tract gradient lower than 30 mmHg.
4 secondary outcomes
Major surgery-related adverse events
Time frame: 30 days
LVOT gradient
Time frame: through study completion, an average of 2 years
Maximum interventricular septal thickness
Time frame: through study completion, an average of 2 years
New York Heart Association functional scale
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 30309466Liu L, Li J, Zuo L, Zhang J, Zhou M, Xu B, Hahn RT, Leon MB, Hsi DH, Ge J, Zhou X, Zhang J, Ge S, Xiong L. Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy. J Am Coll Cardiol. 2018 Oct 16;72(16):1898-1909. doi: 10.1016/j.jacc.2018.07.080.
- Background: PubMed 35353129Zhou M, Ta S, Hahn RT, Hsi DH, Leon MB, Hu R, Zhang J, Zuo L, Li J, Wang J, Wang B, Zhu X, Liu J, Han Y, Li X, Xu B, Zhang L, Hou L, Han C, Liu J, Liu L. Percutaneous Intramyocardial Septal Radiofrequency Ablation in Patients With Drug-Refractory Hypertrophic Obstructive Cardiomyopathy. JAMA Cardiol. 2022 May 1;7(5):529-538. doi: 10.1001/jamacardio.2022.0259.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liwen Liu, Ph.D, M.D. principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, Obstructive, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety composite outcome (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.