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Completed

NCT Number: NCT06540183

Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy, Obstructive Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Percutaneous Intramyocardial Septal Radiofrequency Ablation

Procedure

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.

Primary outcomes

  1. 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.

  2. Feasibility outcome

    Time frame: 6 months

    The proportion of patients with a peak left ventricle outflow tract gradient lower than 30 mmHg.

Secondary outcomes

  1. Major surgery-related adverse events

    Time frame: 30 days

    Emergency surgery, severe pericardial tamponade, conduction block due to deviation in ablation range, surgery related ventricular septal perforation, stroke and malignant arrhythmias.

  2. LVOT gradient

    Time frame: through study completion, an average of 2 years

    Left ventricular outflow tract gradient as measured by echocardiography.

  3. Maximum interventricular septal thickness

    Time frame: through study completion, an average of 2 years

    Maximum septal thickness as measured by echocardiography.

  4. New York Heart Association functional scale

    Time frame: through study completion, an average of 2 years

    New York Heart Association class, including grade I, grade II, grade III, grade IV. A higher grade means worse heart function.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Percutaneous Intramyocardial Septal Radiofrequency Ablation for Drug-refractory Obstructive Hypertrophic Cardiomyopathy in Children and Adolescents: An Early Feasibility Study

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Jul 15, 2026

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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