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

N/AActive Not RecruitingNCT06604169

China National Center for Cardiovascular Diseases589 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

589

Conditions

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

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fuwai hospital

Beijing, China, China

Outcomes

Primary Outcomes

the failure rate of S-ICD screening

S-ICD screening failed

Time frame: 3 months

The inappropriate shock event

The incidence of inappropriate shock event

Time frame: 3 months

Data from ClinicalTrials.gov

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