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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04373876
Other study ID # S-ICD-ITA
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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