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

Active, not recruiting

• Conditions: HCM - Hypertrophic Cardiomyopathy; S-ICD System (implantable Defibrillator)

• Registration Number: NCT06604169
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2027-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 589

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the failure rate of S-ICD screening	3 months	S-ICD screening failed
The inappropriate shock event	3 months	The incidence of inappropriate shock event

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, China