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).
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.
Study Type
OBSERVATIONAL
Enrollment
2,056
ICD single, dual or triple chamber, upgrade, replacement or primo implant
LKH Feldkirch
Feldkirchen bei Mattighofen, Austria
LKH Innsbruck
Innsbruck, Austria
Kepler Universitatsklinikum GmbH
Linz, Austria
LKH St. Polten
Pölten, Austria
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Royal Alexandra Hospital
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
Time frame: 2 years
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at implant
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Edmonton, Canada
HDM (CHUM) Montreal
Montreal, Canada
HSCM Montreal
Montreal, Canada
IUCPQ Quebec
Québec, Canada
Sherbrooke
Québec, Canada
...and 92 more locations