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Residual or Recurrent Obstruction After Septal Myectomy

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05687487
Collaborator
(none)
56
Enrollment
97
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    56 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Residual or Recurrent Obstruction After Septal Myectomy in Young Children and Infants With Hypertrophic Cardiomyopathy
    Actual Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Feb 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. death [through study completion, an average of 1 year]

      postoperative death during follow-up

    Secondary Outcome Measures

    1. recurrent obstruction [through study completion, an average of 1 year]

      postoperative recurrent obstruction during follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences, Fuwai Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Yan, Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
    ClinicalTrials.gov Identifier:
    NCT05687487
    Other Study ID Numbers:
    • 2020-I2M-C&T-B-060
    First Posted:
    Jan 18, 2023
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jun Yan, Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
    Septal myectomy
    Residual or recurrent obstruction
    children and infants
    hypertrophic obstructive cardiomyopathy
    Additional relevant MeSH terms:
    Cardiomyopathies
    Cardiomyopathy, Hypertrophic
    Hypertrophy

    Study Results

    No Results Posted as of Jan 18, 2023