S-ICD French Cohort Study (HONEST)

Recruiting

• Conditions: Implantable Defibrillator User; Sudden Cardiac Death

• Registration Number: NCT05302115
• Lead Sponsor: Paris Sudden Death Expertise Center

Brief Summary

Implantable cardioverter-defibrillators have been proven to be effective in the prevention of sudden cardiac death in high-risk patients. However, it is well acknowledged that such a strategy could be optimised, especially through new technologies/devices. Data on the entirely sub-cutaneous implantable cardioverter defibrillator (S-ICD) published so far come from high-volume centers and/or selected populations. The HONEST Cohort -taking the opportunity of a unique scenario with a single manufacturer and remote monitoring system available- aims to collect retrospectively baseline information as well as follow-up of all patients implanted with an S-ICD in France since the first implant in October 13, 2012 until December 31, 2019. An extended prospective yearly follow-up will be carried out since January 1, 2020 until December 31, 2024.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-13
• Primary Completion: 2019-12-31
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2022-03-20
• Study First Posted: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-07
• Last Update Posted: 2022-05-12
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• All patients who require S-ICD implantation (new or battery replacement)

Exclusion Criteria

• Refusal of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ventricular Arrhythmias	Through study completion, an average of 5 years	Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation
Device-Related Complications	Through study completion, an average of 5 years	Rate of complications related to ICD including inappropriate therapies, infection, lead or generator dysfunction
Overall and Specific Mortalities	Through study completion, an average of 5 years	Overall mortality and causes of death

Secondary Outcome Measures

Name	Time	Method
Early Device-Related Complications	3 months	Complications occurring within the 3 months following implantation
Late Device-Related Complications	Through study completion, an average of 5 year	Complications occurring after 3 months following implantation
Stratified Analyses by Sex, Underlying Heart Disease	Through study completion, an average of 5 year	Primary and secondary outcomes studied by sex and types of heart diseases

Trial Locations

Locations (1)

Paris Cardiovascular Research Center (HONEST Investigators); 🇫🇷 Paris, France