Residual or Recurrent Obstruction After Septal Myectomy

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

Official title:

Residual or Recurrent Obstruction After Septal Myectomy in Young Children and Infants With Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687487
• Other study ID #: 2020-I2M-C&T-B-060
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: February 1, 2021

Study information

• Verified date: January 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of hypertrophic obstructive cardiomyopathy (HOCM)

• Age young than 14 years

• Patients who have undergone septal myectomy

Exclusion Criteria:

• older than 14 years old;

• secondary left ventricular hypertrophy (LVH) related to subaortic stenosis or aortic stenosis.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	postoperative death during follow-up	through study completion, an average of 1 year
Secondary	recurrent obstruction	postoperative recurrent obstruction during follow-up	through study completion, an average of 1 year