Clinical trial NCT02341768: Clinical and Device Functional Assessment of Real World ICD Patients
Official title: Clinical and Device Functional Assessment of Real World ICD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrythmia
Implantable Cardioverter Defibrillator
Keywords: clinical and device functional information
"real world" ICD patient population
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2015-01-19
Enrollment: 2056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim of this study is to include all patients from a global "real world" (standard of care) population at participating centers and will reference the indication and the contra-indications specified in the guidelines and IFUs.

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.

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

Primary outcomes:
measure: 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)
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: at implantation or hospital discharge
measure: The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve)
timeFrame: at 12 months
measure: The predictors of mortality and cardiac related hospitalization at 12 and 24 months
timeFrame: at 12 and 24 months
measure: The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee
timeFrame: at 12 and 24 months
measure: 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)
timeFrame: at implant
Other outcomes:
Locations:
city: Feldkirchen bei Mattighofen
country: Austria
facility: LKH Feldkirch
city: Innsbruck
country: Austria
facility: LKH Innsbruck
city: Linz
country: Austria
facility: Kepler Universitatsklinikum GmbH
city: Polten
country: Austria
facility: LKH St. Polten
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
city: Montreal
country: Canada
facility: HDM (CHUM) Montreal
city: Montreal
country: Canada
facility: HSCM Montreal
city: Quebec
country: Canada
facility: IUCPQ Quebec
city: Quebec
country: Canada
facility: Sherbrooke
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno
city: Brno
country: Czechia
facility: Fakultni Nemocnice U svaté Anny v Brno
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Angers
country: France
facility: CHU Angers
city: Annecy
country: France
facility: CH Annecy Genevois
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen
city: Clamart
country: France
facility: H.I.A Percy
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Jossigny
country: France
facility: CH de Marne la Vallée
city: Le Coudray
country: France
facility: Hôpital Louis Pasteur
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: CH St Joseph St Luc
city: Marseille
country: France
facility: Hôpital la Timone
city: Marseille
country: France
facility: Hôpital Nord Marseille
city: Massy
country: France
facility: Hôpital Jacques Cartier
city: Montpellier
country: France
facility: CHU A de Villeneuve
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Nancy
country: France
facility: CHRU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nimes
country: France
facility: CHU de Nimes
city: Paris 15
country: France
facility: HEGP
city: Paris
country: France
facility: La Pitié Salpétrière
city: Pau
country: France
facility: CHU François Mitterand
city: Perpignan
country: France
facility: CH Perpignan
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHRU de Pontchaillou
city: Rouen
country: France
facility: CHRU de Rouen
city: Valence
country: France
facility: CHU de Valence
city: Villefranche sur Saone
country: France
facility: CH de Villefranche sur Saone
city: Altentreptow
country: Germany
facility: Kardiologische Praxis
city: Bad Bevensen
country: Germany
facility: HGZ Bad Bevensen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus
city: Bonn
country: Germany
facility: Universitatskliniken
city: Darmstadt
country: Germany
facility: Kardiologie Darmstadt
city: Düsseldorf
country: Germany
facility: Universitatskliniken Düsseldorf
city: Hamburg
country: Germany
facility: Albertinen-Krankenhaus
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
city: Kiel
country: Germany
facility: Universität Kiel
city: Lubeck
country: Germany
facility: Universitaetsklinikum Schleswig Holstein
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Markkleeberg
country: Germany
facility: Kardiologische Praxis
city: Neubrandenburg
country: Germany
facility: Dietrich Bonhoeffer Klinikum
city: Wurzburg
country: Germany
facility: Universitatsklinikum
city: Catania
country: Italy
facility: Ospedale Garibaldi Centro
city: Chieti
country: Italy
facility: Ospedale Pol SS Annunziata
city: Chioggia
country: Italy
facility: Presidio Ospedaliero di Chioggia
city: Lucca
country: Italy
facility: Ospital San Luca
city: Mirano
country: Italy
facility: Ospedale Civile
city: Napoli
country: Italy
facility: Osp S Giovanni Bosco
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Napoli
country: Italy
facility: Ospedale Policlinico Federico II
city: Rome
country: Italy
facility: Policlinico Casilino
city: Teramo
country: Italy
facility: Osp. G. Mazzini
city: Trieste
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti
city: Schiedam
country: Netherlands
facility: Vlietland Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Amadora
country: Portugal
facility: Hospital Professor Doutor Fernando Fonseca
city: Lisboa
country: Portugal
facility: CHLC Hospital de Santa Marta
city: Lisboa
country: Portugal
facility: H. Santa Maria
city: Banská Bystrica
country: Slovakia
facility: Susch Hospital
city: Bratislava
country: Slovakia
facility: Nusch Hospital
city: Kosice
country: Slovakia
facility: Vusch Hospital
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario
city: Valencia
country: Spain
facility: H.U La Fe
city: Vigo
country: Spain
facility: CHU de Vigo
city: Lugano
country: Switzerland
facility: Fondazione Cardiocentro Ticino
city: Barnet
country: United Kingdom
facility: Barnet General Hospital
city: Birmingham
country: United Kingdom
facility: Edgbaston
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
city: Dorchester
country: United Kingdom
facility: Dorget County Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Hereford
country: United Kingdom
facility: Wye Valley NHS Trust
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Hospital Ramón y Cajal Ctra. de Colmenar Viejo km 9.100, 28034 Madrid, Spain
name: Javier Moreno, Dr
role: PRINCIPAL_INVESTIGATOR
References: