NCT02341768

Clinical and Device Functional Assessment of Real World ICD Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,056 (actual)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrythmia
• Implantable Cardioverter Defibrillator

Interventions

Type	Name	Description
DEVICE	ICD	ICD single, dual or triple chamber, upgrade, replacement or primo implant

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-11-26
• Completion: 2019-11-26
• First posted: 2015-01-19
• Last updated: 2020-08-17

Locations

102 sites across 12 countries: Austria, Canada, Czechia, France, Germany, Italy, Netherlands, Portugal, Slovakia, Spain, Switzerland, United Kingdom