Experience From the Italian S-ICD Registry (ELISIR)

Luigi Sacco University Hospital

Status: Unknown

Conditions: Implantable Cardiac Defibrillator; Ventricular Arrythmia; Sudden Cardiac Death; Cardiac Arrest

Treatments: Device: Subcutaneous Implantable Cardioverter Defibrillator

Study type: Observational

Funder types: Other

Identifiers

NCT04373876

S-ICD-ITA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age >/= 18 years
• Patients successfully implanted with S-ICD
• Patients able to provide written informed consent or have informed consent as provided by a legal representative