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NCT Number: NCT06604169

An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death

1. To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD. 2. To observe the incidence of IAS in HCM patients with S-ICD implantation and explore the related factors of IAS.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HCM - Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases S-ICD System (implantable Defibrillator)

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, China, 100037

About this study

The study was a multicenter, prospective, observational study that prospectively included HCM patients assessed as meeting the ICD implantation indication at Fuwai Hospital and National Collaborative Hospitals from July 1, 2024 to June 30, 2027, for pre-operation screening of S-ICD, and follow-up of patients eventually implanted with S-ICD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HCM patients assessed as meeting the ICD implantation indication

Exclusion criteria

  • Combined with bradycardia with pacing indications;
  • Frequent monomorphic ventricular tachycardia require ATP therapy;
  • With indications of CRT;
  • Combined with other diseases, life expectancy is less than 1 year.

Treatment and study plan

Primary outcomes

  1. the failure rate of S-ICD screening

    Time frame: 3 months

    S-ICD screening failed

  2. The inappropriate shock event

    Time frame: 3 months

    The incidence of inappropriate shock event

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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