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OpenTrials
Completed

NCT Number: NCT05687487

Residual or Recurrent Obstruction After Septal Myectomy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. death

    Time frame: through study completion, an average of 1 year

    postoperative death during follow-up

Secondary outcomes

  1. recurrent obstruction

    Time frame: through study completion, an average of 1 year

    postoperative recurrent obstruction during follow-up

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2021
First posted
Jan 18, 2023
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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