Clinical and Device Functional Assessment of Real World ICD Patients (CARAT)

MicroPort

Status: Completed

Conditions: Arrythmia; Implantable Cardioverter Defibrillator

Treatments: Device: ICD

Study type: Observational

Funder types: Industry

Identifiers

NCT02341768

RTSY03

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,056 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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