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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

589 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HCM - Hypertrophic Cardiomyopathy S-ICD System (implantable Defibrillator)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No