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Completed
NCT06540183
Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children
Conditions: Hypertrophic Cardiomyopathy, Obstructive
Sex: All
Ages: N/A – 18 Years
Healthy volunteers: No
Enrollment: 23
Sponsor: Xijing Hospital
Location: Xijing Hospital Xi'an Shaanxi
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT06540183). StuddyBuddy aggregates publicly available trial information.