Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in Children

NCT06540183 | Completed

• 1 other identifier: KY20232356
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy, Obstructive

Keywords

Percutaneous Intramyocardial Septal Radiofrequency Ablation; children; hypertrophic cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Safety composite outcome

  The number of people who reach the composite safety outcome (the occurrence of at least one) of the following measured variables: 1) all-cause death; 2) heart failure; 3) ventricular fibrillation.

  30 days

• Feasibility outcome

  The proportion of people with a peak left ventricle outflow tract gradient lower than 30 mmHg or decreased by more than 50%.

  6 months

Secondary Outcomes (4)

• Major surgery-related adverse events

  30 days

• LVOT gradient

  through study completion, an average of 2 years

• Maximum interventricular septal thickness

  through study completion, an average of 2 years

• New York Heart Association functional scale

  through study completion, an average of 2 years

Interventions

Percutaneous intramyocardial septal radiofrequency ablation PROCEDURE

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with obstructive HCM who remain severely symptomatic despite medical therapy or have LVOT obstruction (peak gradient ≥ 50mmHg) underwent percutaneous intramyocardial septal radiofrequency ablation from September 2020 to December 2023. A total of 16 consecutive children younger than 18 were included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

• Liu L, Li J, Zuo L, Zhang J, Zhou M, Xu B, Hahn RT, Leon MB, Hsi DH, Ge J, Zhou X, Zhang J, Ge S, Xiong L. Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy. J Am Coll Cardiol. 2018 Oct 16;72(16):1898-1909. doi: 10.1016/j.jacc.2018.07.080.

  PMID: 30309466 BACKGROUND

• Zhou M, Ta S, Hahn RT, Hsi DH, Leon MB, Hu R, Zhang J, Zuo L, Li J, Wang J, Wang B, Zhu X, Liu J, Han Y, Li X, Xu B, Zhang L, Hou L, Han C, Liu J, Liu L. Percutaneous Intramyocardial Septal Radiofrequency Ablation in Patients With Drug-Refractory Hypertrophic Obstructive Cardiomyopathy. JAMA Cardiol. 2022 May 1;7(5):529-538. doi: 10.1001/jamacardio.2022.0259.

  PMID: 35353129 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Liwen Liu, Ph.D, M.D.

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 7, 2024
• Last Updated: August 6, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)