Last updated on March 2019

Clinical and Device Functional Assessment of Real World ICD Patients


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02341768

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LKH Feldkirch

Feldkirchen bei Mattighofen, Austria
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LKH Innsbruck

Innsbruck, Austria
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HSCM Montreal

Montreal, Canada
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IUCPQ Quebec

Quebec, QC Canada
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Sherbrooke

Quebec, QC Canada
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CHU Angers

Angers, France
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H.I.A Percy

Clamart, France
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CHU de Clermont-Ferrand

Clermont-Ferrand, France
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HEGP

Paris 15, France
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CH Perpignan

Perpignan, France
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CH de Villefranche sur Saone

Villefranche sur Saone, France
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Kardiologische Praxis

Altentreptow, Germany
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HGZ Bad Bevensen

Bad Bevensen, Germany
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Kardiologische Praxis

Markkleeberg, Germany
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Hadassah

Hadassah, Israel
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Sheba

Ramat Hadassa, Israel
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Rambam

Rambam, Israel
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Soroka

Soroka, Israel
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Vlietland Ziekenhuis

Schiedam, Netherlands
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Isala Klinieken

Zwolle, Netherlands
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Nusch Hospital

Bratislava, Slovakia
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Hospital Son Ll tzer

Palma de Mallorca, Spain
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H.U La Fe

Valencia, Spain
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Edgbaston

Birmingham, United Kingdom
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Dorget County Hospital

Dorchester, United Kingdom
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Wye Valley NHS Trust

Hereford, United Kingdom
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Glenfield Hospital

Leicester, United Kingdom
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Northampton General Hospital

Northampton, United Kingdom
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Northern General Hospital

Sheffield, United Kingdom
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Susch Hospital

Banská Bystrica, Slovakia
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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