Experience From the Italian S-ICD Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sudden Cardiac Death Cardiac Arrest Ventricular Arrythmia Implantable Cardiac Defibrillator

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Subcutaneous Implantable Cardioverter Defibrillator

Patients implanted with a totally subcutaneous defibrillator system

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No