Experience From the Italian S-ICD Registry

Luigi Sacco University Hospital500 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Sudden Cardiac Death Cardiac Arrest Ventricular Arrythmia Implantable Cardiac Defibrillator

Interventions

Subcutaneous Implantable Cardioverter DefibrillatorDEVICE

Patients implanted with a totally subcutaneous defibrillator system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Pitié-Salpêtrière University Hospital

Paris, France

RECRUITING

Asklepios Klinik St. Georg

Outcomes

Primary Outcomes

Mortality

Overall or arrhythmic mortality

Time frame: 2 years

Appropriate shocks

Appropriate therapies delivered by the devices

Time frame: 2 years

Inappropriate shocks

Inappropriate therapies delivered by the devices

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.