AzTrials
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ArrythmiaCARATNCT02341768

Clinical and Device Functional Assessment of Real World ICD Patients

An observational study of Arrythmia and Implantable Cardioverter Defibrillator, run by MicroPort CRM at 102 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ICD
Type of treatment
Medical device
How many people
2,056 participants
Where
102 sitesin 12 countries
Study dates
Jun 2015to 26 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

102 sites in 12 countries.

102 sites in 12 countries

France32 sites

  • CHU Angers

    Angers

  • CH Annecy Genevois

    Annecy

  • Clinique Rhône Durance

    Avignon

  • CHU de Bordeaux

    Bordeaux

  • CHU de Brest

    Brest

  • CHU de Caen

    Caen

  • H.I.A Percy

    Clamart

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

  • CHU Henri Mondor

    Créteil

  • CHU de Grenoble

    Grenoble

  • CH de Marne la Vallée

    Jossigny

  • Hôpital Louis Pasteur

    Le Coudray

  • CHRU de Lille

    Lille

  • CH St Joseph St Luc

    Lyon

  • Hôpital la Timone

    Marseille

  • Hôpital Nord Marseille

    Marseille

  • Hôpital Jacques Cartier

    Massy

  • CHU A de Villeneuve

    Montpellier

  • Clinique du Millénaire

    Montpellier

  • CHRU de Nancy

    Nancy

  • CHU de Nantes

    Nantes

  • Nouvelles Cliniques Nantaises

    Nantes

  • CHU de Nimes

    Nîmes

  • HEGP

    Paris

  • La Pitié Salpétrière

    Paris

  • CHU François Mitterand

    Pau

  • CH Perpignan

    Perpignan

  • CHU de Poitiers

    Poitiers

  • CHRU de Pontchaillou

    Rennes

  • CHRU de Rouen

    Rouen

  • CHU de Valence

    Valence

  • CH de Villefranche sur Saone

    Villefranche-sur-Saône

Other trials in France

Germany15 sites

  • Kardiologische Praxis

    Altentreptow

  • HGZ Bad Bevensen

    Bad Bevensen

  • Herz- und Diabeteszentrum

    Bad Oeynhausen

  • Evangelisches Krankenhaus

    Bielefeld

  • Universitatskliniken

    Bonn

  • Kardiologie Darmstadt

    Darmstadt

  • Universitatskliniken Düsseldorf

    Düsseldorf

  • Albertinen-Krankenhaus

    Hamburg

  • Cardiologicum Hamburg

    Hamburg

  • Universität Kiel

    Kiel

  • Universitaetsklinikum Schleswig Holstein

    Lübeck

  • Universitätsklinikum Magdeburg

    Magdeburg

  • Kardiologische Praxis

    Markkleeberg

  • Dietrich Bonhoeffer Klinikum

    Neubrandenburg

  • Universitatsklinikum

    Würzburg

Other trials in Germany

Italy11 sites

  • Ospedale Garibaldi Centro

    Catania

  • Ospedale Pol SS Annunziata

    Chieti

  • Presidio Ospedaliero di Chioggia

    Chioggia

  • Ospital San Luca

    Lucca

  • Ospedale Civile

    Mirano

  • Osp S Giovanni Bosco

    Naples

  • Ospedale Cardarelli

    Naples

  • Ospedale Policlinico Federico II

    Naples

  • Policlinico Casilino

    Rome

  • Osp. G. Mazzini

    Teramo

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti

    Trieste

Other trials in Italy

Spain11 sites

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital Virgen de las Nieves

    Granada

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario Clínico San Carlos

    Madrid

  • Hospital Universitario Puerta de Hierro

    Majadahonda

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital Central de Asturias

    Oviedo

  • Hospital Son Llàtzer

    Palma de Mallorca

  • Complejo Hospitalario Universitario

    Santiago de Compostela

  • H.U La Fe

    Valencia

  • CHU de Vigo

    Vigo

Other trials in Spain

United Kingdom10 sites

  • Barnet General Hospital

    Barnet

  • Edgbaston

    Birmingham

  • Papworth Hospital NHS Foundation Trust

    Cambridge

  • Dorget County Hospital

    Dorchester

  • Royal Infirmary of Edinburgh

    Edinburgh

  • Wye Valley NHS Trust

    Hereford

  • Glenfield Hospital

    Leicester

  • King's College Hospital

    London

  • Northampton General Hospital

    Northampton

  • Northern General Hospital

    Sheffield

Other trials in United Kingdom

Canada6 sites

  • Royal Alexandra Hospital

    Edmonton

  • HDM (CHUM) Montreal

    Montreal

  • HSCM Montreal

    Montreal

  • IUCPQ Quebec

    Québec

  • Sherbrooke

    Québec

  • Sunnybrook Health Sciences Center

    Toronto, Ontario

Other trials in Canada

Austria4 sites

  • LKH Feldkirch

    Feldkirchen bei Mattighofen

  • LKH Innsbruck

    Innsbruck

  • Kepler Universitatsklinikum GmbH

    Linz

  • LKH St. Polten

    Pölten

Other trials in Austria

Portugal4 sites

  • Hospital Garcia de Orta

    Almada

  • Hospital Professor Doutor Fernando Fonseca

    Amadora

  • CHLC Hospital de Santa Marta

    Lisbon

  • H. Santa Maria

    Lisbon

Other trials in Portugal

Czechia3 sites

  • Fakultni Nemocnice Brno

    Brno

  • Fakultni Nemocnice U svaté Anny v Brno

    Brno

  • Fakultni Nemocnice Olomouc

    Olomouc

Other trials in Czechia

Slovakia3 sites

  • Susch Hospital

    Banská Bystrica

  • Nusch Hospital

    Bratislava

  • Vusch Hospital

    Košice

Other trials in Slovakia

Netherlands2 sites

  • Vlietland Ziekenhuis

    Schiedam

  • Isala Klinieken

    Zwolle

Other trials in Netherlands

Switzerland1 site

  • Fondazione Cardiocentro Ticino

    Lugano

Other trials in Switzerland

About this study

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).

Read the 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.

Being tested
ICD
Keywords
clinical and device functional information, "real world" ICD patient population
Medical subject headings
Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICDDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (5)

  1. 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.

    as reported by the sites on the AE eCRF

    Measured: at implantation or hospital discharge

  2. The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve)

    as reported by the sites with AE

    Measured: at 12 months

  3. The predictors of mortality and cardiac related hospitalization at 12 and 24 months

    as reported by the sites with AE and medical history information

    Measured: at 12 and 24 months

  4. The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee

    based on therapies delivered recorder on device file, and verified by a dedicated committee

    Measured: at 12 and 24 months

  5. 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)

    based on the patient's medical history and reason for implant as reported by the investigators

    Measured: at implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2015 (estimated)
  2. Study startJun 2015
  3. Primary completion26 Nov 2019
  4. Study completion26 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,056 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02341768
Sponsor's protocol ID
RTSY03
Acronym
CARAT
Status last verified
Aug 2020
First submitted
12 Jan 2015
Last updated
17 Aug 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Arrythmia and Implantable Cardioverter Defibrillator, run by MicroPort CRM at 102 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in France, Germany, Italy, Spain, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02341768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.

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