Experience From the Italian S-ICD Registry

Cardiac Arrest Clinical Trial

— ELISIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04373876
• Other study ID #: S-ICD-ITA
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: April 2021
• Source: Luigi Sacco University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Subcutaneous Implantable Cardioverter Defibrillator
Patients implanted with a totally subcutaneous defibrillator system

Locations

Country	Name	City	State
France	Pitié-Salpêtrière University Hospital	Paris
Germany	Asklepios Klinik St. Georg	Hamburg
Italy	Presidio Ospedaliero G. Salesi	Ancona
Italy	Presidio Ospedaliero Di Anzio e Nettuno	Anzio	Rome
Italy	Policlinico Sant'Orsola-Malpighi	Bologna
Italy	Spedali Civili di Brescia	Brescia
Italy	Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"	Castrovillari	Cosenza
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Ospedale Vito Fazzi	Lecce
Italy	Presidio Ospedaliero G. B. Grassi	Lido Di Ostia	Rome
Italy	Centro Cardiologico Monzino, IRCCS	Milan
Italy	IRCCS Ospedale San Raffaele	Milan
Italy	Ospedale Luigi Sacco - Polo Universitario	Milan
Italy	Ospedale San Gerardo	Monza
Italy	Ospedale San Filippo Neri	Rome
Italy	Policlinico Umberto I	Rome
Italy	Policlinico Universitario Campus Bio-Medico	Rome
Switzerland	University Hospital of Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Luigi Sacco University Hospital

Countries where clinical trial is conducted

France,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Overall or arrhythmic mortality	2 years
Primary	Appropriate shocks	Appropriate therapies delivered by the devices	2 years
Primary	Inappropriate shocks	Inappropriate therapies delivered by the devices	2 years