NCT06604169

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 589 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-07-31
• Completion: 2028-07-31
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China