Clinical and Device Functional Assessment of Real World ICD Patients (CARAT)

August 14, 2020 updated by: MicroPort CRM

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: ICD

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.

Study Type

Observational

Enrollment (Actual)

2056

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Feldkirchen bei Mattighofen, Austria
    - LKH Feldkirch
  - Innsbruck, Austria
    - LKH Innsbruck
  - Linz, Austria
    - Kepler Universitätsklinikum GmbH
  - Polten, Austria
    - LKH St. Pölten
Canada
- - Edmonton, Canada
    - Royal Alexandra Hospital
  - Montreal, Canada
    - HDM (CHUM) Montreal
  - Montreal, Canada
    - HSCM Montreal
  - Quebec, Canada
    - IUCPQ Quebec
  - Quebec, Canada
    - Sherbrooke
- Ontario
  - Toronto, Ontario, Canada
    - Sunnybrook Health Sciences Center
Czechia
- - Brno, Czechia
    - Fakultni nemocnice Brno
  - Brno, Czechia
    - Fakultni Nemocnice U svaté Anny v Brno
  - Olomouc, Czechia
    - Fakultni nemocnice Olomouc
France
- - Angers, France
    - CHU Angers
  - Annecy, France
    - CH Annecy Genevois
  - Avignon, France
    - Clinique Rhône Durance
  - Bordeaux, France
    - CHU de Bordeaux
  - Brest, France
    - CHU de Brest
  - Caen, France
    - CHU de CAEN
  - Clamart, France
    - H.I.A Percy
  - Clermont-Ferrand, France
    - CHU de Clermont-Ferrand
  - Créteil, France
    - CHU Henri Mondor
  - Grenoble, France
    - CHU de Grenoble
  - Jossigny, France
    - CH de Marne la Vallée
  - Le Coudray, France
    - Hôpital Louis Pasteur
  - Lille, France
    - CHRU de Lille
  - Lyon, France
    - Ch St Joseph St Luc
  - Marseille, France
    - Hôpital La Timone
  - Marseille, France
    - Hôpital Nord Marseille
  - Massy, France
    - Hôpital Jacques Cartier
  - Montpellier, France
    - Clinique du Millénaire
  - Montpellier, France
    - CHU A de Villeneuve
  - Nancy, France
    - CHRU de Nancy
  - Nantes, France
    - CHU de Nantes
  - Nantes, France
    - Nouvelles Cliniques Nantaises
  - Nimes, France
    - CHU de Nimes
  - Paris, France
    - La Pitié Salpêtrière
  - Paris 15, France
    - HEGP
  - Pau, France
    - CHU François Mitterand
  - Perpignan, France
    - CH Perpignan
  - Poitiers, France
    - CHU de Poitiers
  - Rennes, France
    - CHRU de Pontchaillou
  - Rouen, France
    - CHRU de Rouen
  - Valence, France
    - CHU de Valence
  - Villefranche sur Saone, France
    - CH de Villefranche sur Saône
Germany
- - Altentreptow, Germany
    - Kardiologische Praxis
  - Bad Bevensen, Germany
    - HGZ Bad Bevensen
  - Bad Oeynhausen, Germany
    - Herz- und Diabeteszentrum
  - Bielefeld, Germany
    - Evangelisches Krankenhaus
  - Bonn, Germany
    - Universitatskliniken
  - Darmstadt, Germany
    - Kardiologie Darmstadt
  - Düsseldorf, Germany
    - Universitätskliniken Düsseldorf
  - Hamburg, Germany
    - Cardiologicum Hamburg
  - Hamburg, Germany
    - Albertinen-Krankenhaus
  - Kiel, Germany
    - Universität Kiel
  - Lubeck, Germany
    - Universitaetsklinikum Schleswig Holstein
  - Magdeburg, Germany
    - Universitätsklinikum Magdeburg
  - Markkleeberg, Germany
    - Kardiologische Praxis
  - Neubrandenburg, Germany
    - Dietrich Bonhoeffer Klinikum
  - Wurzburg, Germany
    - Universitätsklinikum
Italy
- - Catania, Italy
    - Ospedale Garibaldi Centro
  - Chieti, Italy
    - Ospedale Pol SS Annunziata
  - Chioggia, Italy
    - Presidio Ospedaliero di Chioggia
  - Lucca, Italy
    - Ospital San Luca
  - Mirano, Italy
    - Ospedale Civile
  - Napoli, Italy
    - Ospedale Cardarelli
  - Napoli, Italy
    - Osp S Giovanni Bosco
  - Napoli, Italy
    - Ospedale Policlinico Federico II
  - Rome, Italy
    - Policlinico Casilino
  - Teramo, Italy
    - Osp. G. Mazzini
  - Trieste, Italy
    - Azienda Ospedaliero-Universitaria Ospedali Riuniti
Netherlands
- - Schiedam, Netherlands
    - Vlietland Ziekenhuis
  - Zwolle, Netherlands
    - Isala Klinieken
Portugal
- - Almada, Portugal
    - Hospital Garcia de Orta
  - Amadora, Portugal
    - Hospital Professor Doutor Fernando Fonseca
  - Lisboa, Portugal
    - CHLC Hospital de Santa Marta
  - Lisboa, Portugal
    - H. Santa Maria
Slovakia
- - Banská Bystrica, Slovakia
    - Susch Hospital
  - Bratislava, Slovakia
    - Nusch Hospital
  - Kosice, Slovakia
    - Vusch Hospital
Spain
- - Barcelona, Spain
    - Hospital Clinic de Barcelona
  - Granada, Spain
    - Hospital Virgen de las Nieves
  - Madrid, Spain
    - Hospital Ramón y Cajal
  - Madrid, Spain
    - Hospital Universitario Clínico San Carlos
  - Majadahonda, Spain
    - Hospital Universitario Puerta de Hierro
  - Malaga, Spain
    - Hospital Universitario Virgen de la Victoria
  - Oviedo, Spain
    - Hospital Central de Asturias
  - Palma de Mallorca, Spain
    - Hospital Son Llatzer
  - Santiago de Compostela, Spain
    - Complejo Hospitalario Universitario
  - Valencia, Spain
    - H.U La Fe
  - Vigo, Spain
    - CHU de Vigo
Switzerland
- - Lugano, Switzerland
    - Fondazione Cardiocentro Ticino
United Kingdom
- - Barnet, United Kingdom
    - Barnet General Hospital
  - Birmingham, United Kingdom
    - Edgbaston
  - Cambridge, United Kingdom
    - Papworth Hospital NHS Foundation Trust
  - Dorchester, United Kingdom
    - Dorget County Hospital
  - Edinburgh, United Kingdom
    - Royal Infirmary of Edinburgh
  - Hereford, United Kingdom
    - Wye Valley NHS Trust
  - Leicester, United Kingdom
    - Glenfield Hospital
  - London, United Kingdom
    - King's College Hospital
  - Northampton, United Kingdom
    - Northampton General Hospital
  - Sheffield, United Kingdom
    - Northern General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) Time Frame: 2 years	Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Time Frame: at implantation or hospital discharge	as reported by the sites on the AE eCRF	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) Time Frame: at 12 months	as reported by the sites with AE	at 12 months
The predictors of mortality and cardiac related hospitalization at 12 and 24 months Time Frame: at 12 and 24 months	as reported by the sites with AE and medical history information	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 Time Frame: at 12 and 24 months	based on therapies delivered recorder on device file, and 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) Time Frame: at implant	based on the patient's medical history and reason for implant as reported by the investigators	at implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

Investigators

Principal Investigator: Javier Moreno, Dr, Hospital Ramón y Cajal Ctra. de Colmenar Viejo km 9.100, 28034 Madrid, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

November 26, 2019

Study Completion (Actual)

November 26, 2019

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

August 17, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RTSY03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.