Status:
COMPLETED
Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children
Lead Sponsor:
Xijing Hospital
Conditions:
Hypertrophic Cardiomyopathy, Obstructive
Eligibility:
All Genders
Up to 18 years
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 functi...
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 chi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 7 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06540183
Start Date
September 1 2020
End Date
June 7 2024
Last Update
August 6 2024
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032