Cardiac Arrest, Implantable Cardiac Defibrillator, Sudden Cardiac Death, Ventricular Arrythmia
Conditions
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.
Interventions
Patients implanted with a totally subcutaneous defibrillator system
Sponsors
Luigi Sacco University Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 2 years | Overall or arrhythmic mortality |
| Appropriate shocks | 2 years | Appropriate therapies delivered by the devices |
| Inappropriate shocks | 2 years | Inappropriate therapies delivered by the devices |
Countries
France, Germany, Italy, Switzerland
Outcome results
None listed