Residual or Recurrent Obstruction After Septal Myectomy

NCT05687487 | Completed

• 1 other identifier: 2020-I2M-C&T-B-060
• Study Type: observational
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to report the outcomes after septal myectomy in young children and infants and identify the mechanisms of residual or recurrent obstruction after surgery. in The main question\[s\] it aims to answer are:

• What is the early and mid-term results of septal myectomy in young children and infants with severe and extensive obstructive hypertrophic cardiomyopathy (HCM)?
• What are the mechanisms of residual or recurrent obstruction? Echocardiography and clinical course of children and infants under the age of 14 who underwent septal myectomy for hypertrophic obstructive cardiomyopathy from January 2013 to December 2020 will be followed up.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

Septal myectomy; Residual or recurrent obstruction; children and infants; hypertrophic obstructive cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• death

  postoperative death during follow-up

  through study completion, an average of 1 year

Secondary Outcomes (1)

• recurrent obstruction

  through study completion, an average of 1 year

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with HOCM who remain severely symptomatic despite medical therapy or have a particularly high resting LVOT gradients (\>100mmHg) underwent septal myectomy by the same surgeon Y from January 2013 to December 2020. A total of 56 consecutive children younger than 14 were included. All patients were on Beta blockers therapy and symptomatic.

You may qualify if:

• Clinical diagnosis of hypertrophic obstructive cardiomyopathy (HOCM)
• Age young than 14 years
• Patients who have undergone septal myectomy

You may not qualify if:

• older than 14 years old;
• secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Related Publications (1)

• Dong S, Du C, Song J, Dong J, Meng H, Xu H, Sun Y, Zou M, Li S, Yan J. Residual or recurrent obstruction after septal myectomy in young children and infants with hypertrophic cardiomyopathy: cohort study. Int J Surg. 2023 Jun 1;109(6):1699-1707. doi: 10.1097/JS9.0000000000000426.

  PMID: 37165977 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Bites and Stings

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 18, 2023
• Study Start: January 1, 2013
• Primary Completion: December 31, 2020
• Study Completion: February 1, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01