Obstructive hypertrophic cardiomyopathy
Conditions
Interventions
Test group:percutaneous intramyocardial septal radiofrequency ablation, PIMSRA
Sponsors
The First Affiliated Hospital of the Air Force Medical University (Xijing Hospital).
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1) Age 3-14 years old, gender is not limited; 2) The diagnosis of hypertrophic cardiomyopathy in children is based on the Chinese Guidelines for Hypertrophic Cardiomyopathy 2022: a.. In asymptomatic children without a family history of HCM, HCM is diagnosed when the maximum thickness of the left ventricular wall exceeds 2.5 standard deviations from the predicted normal, i.e., z-score (defined as the number of standard deviations from normal for children of the same age) > 2.5; b. For children with a clear family history of HCM or positive test for the causative gene, a cut-off value of z->2 is recommended; 3) Left ventricular outflow tract (LVOT) differential pressure >= 50 mmHg at rest or after excitation; 4) The child still has symptoms such as dyspnea, chest tightness, and chest pain (NYHA cardiac function >= grade II) after drug treatment (>= 3 months), or has other activity-related symptoms (such as syncope or presyncopal state), which is related to left ventricular outflow tract obstruction, affecting the child's daily activities and quality of life; 5) If the clinical symptoms of the child cannot be assessed, there are other high-risk factors for sudden death (such as ventricular septal thickness z>=6, non-sustained ventricular tachycardia, severe myocardial fibrosis, unexplained syncope, etc.); 6) The child/guardian is able to understand the purpose of the clinical trial, voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of ventricular septal atherectomy surgery; 2. Active infection requires concomitant antibiotic therapy; 3. Concomitant other cardiac conditions requiring surgical treatment; 4. heart failure (symptoms of resting heart failure with left ventricular ejection fraction 2.0 mg/dL or 177 µmol/l) or on dialysis; 7. Occurrence of first-level endpoint events (cardiac arrest rescue survival or implantable cardioverter-defibrillator implantable cardiac defibrillator (ICD) appropriate discharge) and second-level endpoint events (meeting any of the following: hospitalization for heart failure, thromboembolism, end-stage HCM) in the past 6 months; 8. Patients who are allergic to anesthetic drugs and cannot tolerate general anesthesia surgery; 9. Patients who have participated in any clinical trials of drugs and/or medical devices within 1 month prior to this trial; 10. The investigator judged that the patient had poor compliance and was unable to complete the study as required; 11. Those who are judged by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The left ventricular outflow tract pressure gradient decreases by >=50% or the resting left ventricular outflow tract pressure gradient < 30 mmHg;death within 1 month after surgery;Sudden cardiac death and equivalent events 1 month after surgery;Fatal heart failure or heart transplantation and fatal stroke 1 month after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| At 12 months after surgery, the LVOT pressure gradient decreased by >=50% or the resting LVOT pressure gradient <30mmHg;;Maximum ventricular septal thickness at 6 months postoperatively;New York Cardiac Function Classification (NYHA class) at 3 months, 6 months, and 12 months after surgery.;Intraoperative or surgical treatment of coronary artery injury (including cardiac surface coronary artery injury and coronary septal branch injury) required intraoperatively or 30 days after surgery;New arrhythmias affecting hemodynamics, such as atrial tachycardia, atrial fibrillation, ventricular tachycardia, ventricular fibrillation, etc., occur during surgery or 30 days after surgery;New onset of AV block requiring permanent pacemaker implantation occurs during surgery or 30 days postoperatively;Cardiogenic shock during surgery or 30 days postoperatively requires temporary pharmacological or mechanical circulatory support; | — |
Countries
China
Contacts
Public ContactLiwen Liu
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Outcome results
None listed