Experience From the Italian S-ICD Registry

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

• Registration Number: NCT04373876
• Lead Sponsor: Luigi Sacco University Hospital

Brief 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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-10
• Last Update Posted: 2021-04-13
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Appropriate shocks	2 years	Appropriate therapies delivered by the devices
Mortality	2 years	Overall or arrhythmic mortality
Inappropriate shocks	2 years	Inappropriate therapies delivered by the devices

Trial Locations

Locations (18)

University Hospital of Zürich; 🇨🇭 Zürich, Switzerland

Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"; 🇮🇹 Castrovillari, Cosenza, Italy

Presidio Ospedaliero Di Anzio e Nettuno; 🇮🇹 Anzio, Rome, Italy

Pitié-Salpêtrière University Hospital; 🇫🇷 Paris, France

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Presidio Ospedaliero G. Salesi; 🇮🇹 Ancona, Italy

Presidio Ospedaliero G. B. Grassi; 🇮🇹 Lido Di Ostia, Rome, Italy

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy

Policlinico Sant'Orsola-Malpighi; 🇮🇹 Bologna, Italy

Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Firenze, Italy

Centro Cardiologico Monzino, IRCCS; 🇮🇹 Milan, Italy

Ospedale San Gerardo; 🇮🇹 Monza, Italy

Ospedale Vito Fazzi; 🇮🇹 Lecce, Italy

Policlinico Universitario Campus Bio-Medico; 🇮🇹 Rome, Italy

Ospedale San Filippo Neri; 🇮🇹 Rome, Italy

Policlinico Umberto I; 🇮🇹 Rome, Italy

Ospedale Luigi Sacco - Polo Universitario; 🇮🇹 Milan, Italy