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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06604169

Enrollment

589

Registered

2024-09-19

Start date

2024-08-01

Completion date

2028-07-31

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HCM, S-ICD

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results