Clinical and Device Functional Assessment of Real World ICD Patients

Arrythmia Clinical Trial

— CARAT  

Official title:

Clinical and Device Functional Assessment of Real World ICD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341768
• Other study ID #: RTSY03
• Status: Completed
• Start date: June 2015
• Est. completion date: November 26, 2019

Study information

• Verified date: August 2020
• Source: MicroPort CRM
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

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 information / eligibility

• Status: Completed
• Enrollment: 2056
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia
• Implantable Cardioverter Defibrillator

Intervention

Device:
• ICD
ICD single, dual or triple chamber, upgrade, replacement or primo implant

Locations

Country	Name	City	State
Austria	LKH Feldkirch	Feldkirchen bei Mattighofen
Austria	LKH Innsbruck	Innsbruck
Austria	Kepler Universitatsklinikum GmbH	Linz
Austria	LKH St. Polten	Polten
Canada	Royal Alexandra Hospital	Edmonton
Canada	HDM (CHUM) Montreal	Montreal
Canada	HSCM Montreal	Montreal
Canada	IUCPQ Quebec	Quebec
Canada	Sherbrooke	Quebec
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario
Czechia	Fakultni Nemocnice Brno	Brno
Czechia	Fakultni Nemocnice U svaté Anny v Brno	Brno
Czechia	Fakultni Nemocnice Olomouc	Olomouc
France	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	Nimes
France	La Pitié Salpétrière	Paris
France	HEGP	Paris 15
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 Saone
Germany	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	Lubeck
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Kardiologische Praxis	Markkleeberg
Germany	Dietrich Bonhoeffer Klinikum	Neubrandenburg
Germany	Universitatsklinikum	Wurzburg
Italy	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
Netherlands	Vlietland Ziekenhuis	Schiedam
Netherlands	Isala Klinieken	Zwolle
Portugal	Hospital Garcia de Orta	Almada
Portugal	Hospital Professor Doutor Fernando Fonseca	Amadora
Portugal	CHLC Hospital de Santa Marta	Lisboa
Portugal	H. Santa Maria	Lisboa
Slovakia	Susch Hospital	Banská Bystrica
Slovakia	Nusch Hospital	Bratislava
Slovakia	Vusch Hospital	Kosice
Spain	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	Malaga
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
Switzerland	Fondazione Cardiocentro Ticino	Lugano
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Countries where clinical trial is conducted

Austria,  Canada,  Czechia,  France,  Germany,  Italy,  Netherlands,  Portugal,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at implantation or hospital discharge
Secondary	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	at 12 months
Secondary	The predictors of mortality and cardiac related hospitalization at 12 and 24 months	as reported by the sites with AE and medical history information	at 12 and 24 months
Secondary	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	at 12 and 24 months
Secondary	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	at implant