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

NCT06604169 | Active Not Recruiting DMC

• 1 other identifier: S-ICD in HCM
• Study Type: observational
• Target: 589
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD.
2. 2.To observe the incidence of IAS in HCM patients with S-ICD implantation and explore the related factors of IAS.

Conditions

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

Keywords

HCM; S-ICD

Outcome Measures

Primary Outcomes (2)

• the failure rate of S-ICD screening

  S-ICD screening failed

  3 months

• The inappropriate shock event

  The incidence of inappropriate shock event

  3 months

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• HCM patients assessed as meeting the ICD implantation indication

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai hospital

Beijing, China, 100037, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)