Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540183
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Percutaneous Intramyocardial Septal Radiofrequency Ablation for Drug-refractory Obstructive Hypertrophic Cardiomyopathy in Children and Adolescents An Early Feasibility Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 an observational 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None