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Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children

NCT06540183 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2024-08-06

No results posted yet for this study

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.

Conditions

  • Hypertrophic Cardiomyopathy, Obstructive

Interventions

PROCEDURE

Percutaneous intramyocardial septal radiofrequency ablation

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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Liwen Liu, Ph.D, M.D. · Xijing Hospital

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-06-01
Completion
2024-06-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06540183 on ClinicalTrials.gov