Clinical and Device Functional Assessment of Real World ICD Patients

NCT ID: NCT02341768

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2056 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-11-26

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.

Conditions

Arrythmia; Implantable Cardioverter Defibrillator

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

ICD

ICD single, dual or triple chamber, upgrade, replacement or primo implant

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort CRM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Moreno, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital Ramón y Cajal Ctra. de Colmenar Viejo km 9.100, 28034 Madrid, Spain

Locations

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

Edmonton, , Canada

HDM (CHUM) Montreal

Montreal, , Canada

HSCM Montreal

Montreal, , Canada

IUCPQ Quebec

Québec, , Canada

Sherbrooke

Québec, , Canada

Fakultni Nemocnice Brno

Brno, , Czechia

Fakultni Nemocnice U svaté Anny v Brno

Brno, , Czechia

Fakultni Nemocnice Olomouc

Olomouc, , Czechia

CHU Angers

Angers, , France

CH Annecy Genevois

Annecy, , France

Clinique Rhône Durance

Avignon, , France

CHU de Bordeaux

Bordeaux, , France

CHU de Brest

Brest, , France

CHU de Caen

Caen, , France

H.I.A Percy

Clamart, , France

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

CHU Henri Mondor

Créteil, , France

CHU de Grenoble

Grenoble, , France

CH de Marne la Vallée

Jossigny, , France

Hôpital Louis Pasteur

Le Coudray, , France

CHRU de Lille

Lille, , France

CH St Joseph St Luc

Lyon, , France

Hôpital la Timone

Marseille, , France

Hôpital Nord Marseille

Marseille, , France

Hôpital Jacques Cartier

Massy, , France

CHU A de Villeneuve

Montpellier, , France

Clinique du Millénaire

Montpellier, , France

CHRU de Nancy

Nancy, , France

CHU de Nantes

Nantes, , France

Nouvelles Cliniques Nantaises

Nantes, , France

CHU de Nimes

Nîmes, , France

HEGP

Paris, , France

La Pitié Salpétrière

Paris, , France

CHU François Mitterand

Pau, , France

CH Perpignan

Perpignan, , France

CHU de Poitiers

Poitiers, , France

CHRU de Pontchaillou

Rennes, , France

CHRU de Rouen

Rouen, , France

CHU de Valence

Valence, , France

CH de Villefranche sur Saone

Villefranche-sur-Saône, , France

Kardiologische Praxis

Altentreptow, , Germany

HGZ Bad Bevensen

Bad Bevensen, , Germany

Herz- und Diabeteszentrum

Bad Oeynhausen, , Germany

Evangelisches Krankenhaus

Bielefeld, , Germany

Universitatskliniken

Bonn, , Germany

Kardiologie Darmstadt

Darmstadt, , Germany

Universitatskliniken Düsseldorf

Düsseldorf, , Germany

Albertinen-Krankenhaus

Hamburg, , Germany

Cardiologicum Hamburg

Hamburg, , Germany

Universität Kiel

Kiel, , Germany

Universitaetsklinikum Schleswig Holstein

Lübeck, , Germany

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Kardiologische Praxis

Markkleeberg, , Germany

Dietrich Bonhoeffer Klinikum

Neubrandenburg, , Germany

Universitatsklinikum

Würzburg, , Germany

Ospedale Garibaldi Centro

Catania, , Italy

Ospedale Pol SS Annunziata

Chieti, , Italy

Presidio Ospedaliero di Chioggia

Chioggia, , Italy

Ospital San Luca

Lucca, , Italy

Ospedale Civile

Mirano, , Italy

Osp S Giovanni Bosco

Napoli, , Italy

Ospedale Cardarelli

Napoli, , Italy

Ospedale Policlinico Federico II

Napoli, , Italy

Policlinico Casilino

Rome, , Italy

Osp. G. Mazzini

Teramo, , Italy

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Trieste, , Italy

Vlietland Ziekenhuis

Schiedam, , Netherlands

Isala Klinieken

Zwolle, , Netherlands

Hospital Garcia de Orta

Almada, , Portugal

Hospital Professor Doutor Fernando Fonseca

Amadora, , Portugal

CHLC Hospital de Santa Marta

Lisbon, , Portugal

H. Santa Maria

Lisbon, , Portugal

Susch Hospital

Banská Bystrica, , Slovakia

Nusch Hospital

Bratislava, , Slovakia

Vusch Hospital

Košice, , Slovakia

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital Virgen de las Nieves

Granada, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Majadahonda, , Spain

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Hospital Central de Asturias

Oviedo, , Spain

Hospital Son Llàtzer

Palma de Mallorca, , Spain

Complejo Hospitalario Universitario

Santiago de Compostela, , Spain

H.U La Fe

Valencia, , Spain

CHU de Vigo

Vigo, , Spain

Fondazione Cardiocentro Ticino

Lugano, , Switzerland

Barnet General Hospital

Barnet, , United Kingdom

Edgbaston

Birmingham, , United Kingdom

Papworth Hospital NHS Foundation Trust

Cambridge, , United Kingdom

Dorget County Hospital

Dorchester, , United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Wye Valley NHS Trust

Hereford, , United Kingdom

Glenfield Hospital

Leicester, , United Kingdom

King's College Hospital

London, , United Kingdom

Northampton General Hospital

Northampton, , United Kingdom

Northern General Hospital

Sheffield, , United Kingdom

Countries

Austria; Canada; Czechia; France; Germany; Italy; Netherlands; Portugal; Slovakia; Spain; Switzerland; United Kingdom

Other Identifiers

RTSY03

Identifier Type: -

Identifier Source: org_study_id