NCT06604169
Active, not recruiting
Not Applicable
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
China National Center for Cardiovascular Diseases1 site in 1 country589 target enrollmentAugust 1, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HCM - Hypertrophic Cardiomyopathy
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 589
- Locations
- 1
- Primary Endpoint
- the failure rate of S-ICD screening
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
- To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD.
- 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
the failure rate of S-ICD screening
Time Frame: 3 months
S-ICD screening failed
The inappropriate shock event
Time Frame: 3 months
The incidence of inappropriate shock event
Study Sites (1)
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