Clinical and Device Functional Assessment of Real World ICD Patients

Study Overview
=================
Brief Summary
-----------------
The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition. It is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).

Detailed Description
-----------------
For these reasons, it is very important to observe the clinical practice on a large variety of centers and countries, with the objective to collect long term safety and performance data in patients undergoing ICD/CRT-D device implantation (first implant, replacement or upgrade). The safety and performance of the ICDs can be evaluated through the collection of multiple parameters such as, but not limited to: Clinical parameters, like patient demographics and history, procedural and hospital discharge data, as well as the short and long term serious adverse events (death and hospitalization) Device parameters, such as delivered shocks, ATP, or other device therapies Worldwide selected centers will be invited to participate in this prospective study and include their real-world patients treated with Sorin Group commercially available ICDs and CRT-Ds devices.

Official Title
-----------------
Clinical and Device Functional Assessment of Real World ICD Patients

Conditions
-----------------
Arrythmia, Implantable Cardioverter Defibrillator

Intervention / Treatment
-----------------
* Device: ICD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Implanted (first implant, replacement, upgrade) with a Sorin Group ICD/CRT-D device, according to current available guidelines and IFU Signed and dated informed consent (in accordance to local regulation) Exclusion Criteria: Already included in another clinical study that could confound the results of this study Not available for routine follow-up visits Minor age Drug addiction or abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ICD|ICD single, dual or triple chamber, upgrade, replacement or primo implant|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate clinical and device functional information from real world ICD patient population following standard of care at participating centers w/in the different participating countries (Incidence of all death, device,cardiac related hospitalization) | Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious procedural complications or other SAE at implantation or hospital discharge. The data analyzed are those collected from the day of implantation to the day of hospital discharge, with an expected average of 1 week. | as reported by the sites on the AE eCRF | at implantation or hospital discharge | 
| The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve) | as reported by the sites with AE | at 12 months | 
| The predictors of mortality and cardiac related hospitalization at 12 and 24 months | as reported by the sites with AE and medical history information | at 12 and 24 months | 
| The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee | based on therapies delivered recorder on device file, and verified by a dedicated committee | at 12 and 24 months | 
| The evolution of the indication for implant according to guideline (based on the patient's medical history and reason for implant as reported by the investigators) | based on the patient's medical history and reason for implant as reported by the investigators | at implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical and device functional information, real world ICD patient population