NCT04373876

Experience From the Italian S-ICD Registry

Experience From the Long-term Italian Subcutaneous Implantable Cardioverter Defibrillator Registry (ELISIR)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Luigi Sacco University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this registry is to collect data on implant parameters, early, mid and long-term clinical effectiveness of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) therapies in order to better understand how to improve the clinical care of patients and effectiveness of S-ICD therapies.

Detailed description

ISIR is an observational, multicentric registry designed to collect implant and follow-up data of consecutive patients implanted with Subcutaneous Implantable Cardioverter Defibrillator (S-ICD). A number of about 10 enrolling centers is estimated with an overall number of 400 patients. A minimal follow-up of 6 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term effectiveness of S-ICD therapies and safety.

Conditions

• Sudden Cardiac Death
• Cardiac Arrest
• Ventricular Arrythmia
• Implantable Cardiac Defibrillator

Interventions

Type	Name	Description
DEVICE	Subcutaneous Implantable Cardioverter Defibrillator	Patients implanted with a totally subcutaneous defibrillator system

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-05-05
• Last updated: 2021-04-13

Locations

18 sites across 4 countries: France, Germany, Italy, Switzerland

Regulatory

• FDA-regulated device study