Clinical and Device Functional Assessment of Real World ICD Patients
- Conditions
- Implantable Cardioverter DefibrillatorArrythmia
- Registration Number
- NCT02341768
- Lead Sponsor
- MicroPort CRM
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2056
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) 2 years Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant
- Secondary Outcome Measures
Name Time Method 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. at implantation or hospital discharge as reported by the sites on the AE eCRF
The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve) at 12 months as reported by the sites with AE
The predictors of mortality and cardiac related hospitalization at 12 and 24 months at 12 and 24 months as reported by the sites with AE and medical history information
The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee at 12 and 24 months based on therapies delivered recorder on device file, and verified by a dedicated committee
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) at implant based on the patient's medical history and reason for implant as reported by the investigators
Trial Locations
- Locations (101)
Hôpital la Timone
🇫🇷Marseille, France
Kepler Universitatsklinikum GmbH
🇦🇹Linz, Austria
CHRU de Lille
🇫🇷Lille, France
HSCM Montreal
🇨🇦Montreal, Canada
CHU de Nantes
🇫🇷Nantes, France
Osp. G. Mazzini
🇮🇹Teramo, Italy
CH St Joseph St Luc
🇫🇷Lyon, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
HGZ Bad Bevensen
🇩🇪Bad Bevensen, Germany
Evangelisches Krankenhaus
🇩🇪Bielefeld, Germany
Ospedale Civile
🇮🇹Mirano, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti
🇮🇹Trieste, Italy
CHU de Grenoble
🇫🇷Grenoble, France
CHLC Hospital de Santa Marta
🇵🇹Lisboa, Portugal
Sunnybrook Health Sciences Center
🇨🇦Toronto, Ontario, Canada
Fakultni Nemocnice Olomouc
🇨🇿Olomouc, Czechia
Hôpital Louis Pasteur
🇫🇷Le Coudray, France
Clinique du Millénaire
🇫🇷Montpellier, France
Hôpital Jacques Cartier
🇫🇷Massy, France
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
CHRU de Nancy
🇫🇷Nancy, 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
Kardiologische Praxis
🇩🇪Markkleeberg, Germany
Herz- und Diabeteszentrum
🇩🇪Bad Oeynhausen, Germany
Kardiologie Darmstadt
🇩🇪Darmstadt, Germany
Universitatskliniken
🇩🇪Bonn, Germany
Albertinen-Krankenhaus
🇩🇪Hamburg, Germany
Universitatskliniken Düsseldorf
🇩🇪Düsseldorf, Germany
Universitaetsklinikum Schleswig Holstein
🇩🇪Lubeck, Germany
Cardiologicum Hamburg
🇩🇪Hamburg, Germany
Universität Kiel
🇩🇪Kiel, Germany
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Universitatsklinikum
🇩🇪Wurzburg, Germany
Dietrich Bonhoeffer Klinikum
🇩🇪Neubrandenburg, Germany
Ospedale Pol SS Annunziata
🇮🇹Chieti, Italy
Ospedale Garibaldi Centro
🇮🇹Catania, Italy
Presidio Ospedaliero di Chioggia
🇮🇹Chioggia, Italy
Ospital San Luca
🇮🇹Lucca, Italy
Ospedale Cardarelli
🇮🇹Napoli, Italy
Ospedale Policlinico Federico II
🇮🇹Napoli, Italy
Policlinico Casilino
🇮🇹Rome, Italy
Osp S Giovanni Bosco
🇮🇹Napoli, Italy
Hospital Garcia de Orta
🇵🇹Almada, Portugal
Vlietland Ziekenhuis
🇳🇱Schiedam, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Hospital Professor Doutor Fernando Fonseca
🇵🇹Amadora, Portugal
Hospital Universitario Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Dorget County Hospital
🇬🇧Dorchester, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
CH Annecy Genevois
🇫🇷Annecy, France
Hôpital Nord Marseille
🇫🇷Marseille, France
CHU A de Villeneuve
🇫🇷Montpellier, France
Susch Hospital
🇸🇰Banská Bystrica, Slovakia
Nusch Hospital
🇸🇰Bratislava, Slovakia
Vusch Hospital
🇸🇰Kosice, Slovakia
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
HDM (CHUM) Montreal
🇨🇦Montreal, Canada
Sherbrooke
🇨🇦Quebec, Canada
CHU Angers
🇫🇷Angers, France
CHU de Bordeaux
🇫🇷Bordeaux, France
IUCPQ Quebec
🇨🇦Quebec, Canada
CH de Villefranche sur Saone
🇫🇷Villefranche sur Saone, France
H. Santa Maria
🇵🇹Lisboa, Portugal
La Pitié Salpétrière
🇫🇷Paris, France
LKH Innsbruck
🇦🇹Innsbruck, Austria
LKH St. Polten
🇦🇹Polten, Austria
Clinique Rhône Durance
🇫🇷Avignon, France
CHU de Brest
🇫🇷Brest, France
Royal Alexandra Hospital
🇨🇦Edmonton, Canada
Fakultni Nemocnice Brno
🇨🇿Brno, Czechia
CHU de Caen
🇫🇷Caen, France
H.I.A Percy
🇫🇷Clamart, France
CHU de Nimes
🇫🇷Nimes, France
HEGP
🇫🇷Paris 15, France
Fondazione Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Edgbaston
🇬🇧Birmingham, United Kingdom
H.U La Fe
🇪🇸Valencia, Spain
King's College Hospital
🇬🇧London, United Kingdom
CHU Henri Mondor
🇫🇷Créteil, France
Barnet General Hospital
🇬🇧Barnet, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
CHU de Vigo
🇪🇸Vigo, Spain
Hospital Son Llàtzer
🇪🇸Palma de Mallorca, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Complejo Hospitalario Universitario
🇪🇸Santiago de Compostela, Spain
Papworth Hospital NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Glenfield Hospital
🇬🇧Leicester, United Kingdom
LKH Feldkirch
🇦🇹Feldkirchen bei Mattighofen, Austria
CH de Marne la Vallée
🇫🇷Jossigny, France
Wye Valley NHS Trust
🇬🇧Hereford, United Kingdom
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
Fakultni Nemocnice U svaté Anny v Brno
🇨🇿Brno, Czechia