Clinical and Device Functional Assessment of Real World ICD Patients
CARAT
1 other identifier
observational
2,056
12 countries
102
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2019
CompletedAugust 17, 2020
August 1, 2020
4.5 years
January 12, 2015
August 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant
2 years
Secondary Outcomes (5)
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
The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve)
at 12 months
The predictors of mortality and cardiac related hospitalization at 12 and 24 months
at 12 and 24 months
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
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
Interventions
ICD single, dual or triple chamber, upgrade, replacement or primo implant
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MicroPort CRMlead
Study Sites (102)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Moreno, Dr
Hospital Ramón y Cajal Ctra. de Colmenar Viejo km 9.100, 28034 Madrid, Spain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2015
First Posted
January 19, 2015
Study Start
June 1, 2015
Primary Completion
November 26, 2019
Study Completion
November 26, 2019
Last Updated
August 17, 2020
Record last verified: 2020-08