Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None