CARAT: Clinical and Device Functional Assessment of Real World ICD Patients
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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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)
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient Implanted (first implant, replacement, upgrade) with a Sorin Group ICD/CRT-D device, according to current available guidelines and IFU
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Signed and dated informed consent (in accordance to local regulation)
Exclusion Criteria:
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Already included in another clinical study that could confound the results of this study
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Not available for routine follow-up visits
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Minor age
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Drug addiction or abuse
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LKH Feldkirch | Feldkirchen bei Mattighofen | Austria | ||
| 2 | LKH Innsbruck | Innsbruck | Austria | ||
| 3 | Kepler Universitatsklinikum GmbH | Linz | Austria | ||
| 4 | LKH St. Polten | Polten | Austria | ||
| 5 | Sunnybrook Health Sciences Center | Toronto | Ontario | Canada | |
| 6 | Royal Alexandra Hospital | Edmonton | Canada | ||
| 7 | HDM (CHUM) Montreal | Montreal | Canada | ||
| 8 | HSCM Montreal | Montreal | Canada | ||
| 9 | IUCPQ Quebec | Quebec | Canada | ||
| 10 | Sherbrooke | Quebec | Canada | ||
| 11 | Fakultni Nemocnice Brno | Brno | Czechia | ||
| 12 | Fakultni Nemocnice U svaté Anny v Brno | Brno | Czechia | ||
| 13 | Fakultni Nemocnice Olomouc | Olomouc | Czechia | ||
| 14 | CHU Angers | Angers | France | ||
| 15 | CH Annecy Genevois | Annecy | France | ||
| 16 | Clinique Rhône Durance | Avignon | France | ||
| 17 | CHU de Bordeaux | Bordeaux | France | ||
| 18 | CHU de Brest | Brest | France | ||
| 19 | CHU de Caen | Caen | France | ||
| 20 | H.I.A Percy | Clamart | France | ||
| 21 | CHU de Clermont-Ferrand | Clermont-Ferrand | France | ||
| 22 | CHU Henri Mondor | Créteil | France | ||
| 23 | CHU de Grenoble | Grenoble | France | ||
| 24 | CH de Marne la Vallée | Jossigny | France | ||
| 25 | Hôpital Louis Pasteur | Le Coudray | France | ||
| 26 | CHRU de Lille | Lille | France | ||
| 27 | CH St Joseph St Luc | Lyon | France | ||
| 28 | Hôpital la Timone | Marseille | France | ||
| 29 | Hôpital Nord Marseille | Marseille | France | ||
| 30 | Hôpital Jacques Cartier | Massy | France | ||
| 31 | CHU A de Villeneuve | Montpellier | France | ||
| 32 | Clinique du Millénaire | Montpellier | France | ||
| 33 | CHRU de Nancy | Nancy | France | ||
| 34 | CHU de Nantes | Nantes | France | ||
| 35 | Nouvelles Cliniques Nantaises | Nantes | France | ||
| 36 | CHU de Nimes | Nimes | France | ||
| 37 | HEGP | Paris 15 | France | ||
| 38 | La Pitié Salpétrière | Paris | France | ||
| 39 | CHU François Mitterand | Pau | France | ||
| 40 | CH Perpignan | Perpignan | France | ||
| 41 | CHU de Poitiers | Poitiers | France | ||
| 42 | CHRU de Pontchaillou | Rennes | France | ||
| 43 | CHRU de Rouen | Rouen | France | ||
| 44 | CHU de Valence | Valence | France | ||
| 45 | CH de Villefranche sur Saone | Villefranche sur Saone | France | ||
| 46 | Kardiologische Praxis | Altentreptow | Germany | ||
| 47 | HGZ Bad Bevensen | Bad Bevensen | Germany | ||
| 48 | Herz- und Diabeteszentrum | Bad Oeynhausen | Germany | ||
| 49 | Evangelisches Krankenhaus | Bielefeld | Germany | ||
| 50 | Universitatskliniken | Bonn | Germany | ||
| 51 | Kardiologie Darmstadt | Darmstadt | Germany | ||
| 52 | Universitatskliniken Düsseldorf | Düsseldorf | Germany | ||
| 53 | Albertinen-Krankenhaus | Hamburg | Germany | ||
| 54 | Cardiologicum Hamburg | Hamburg | Germany | ||
| 55 | Universität Kiel | Kiel | Germany | ||
| 56 | Universitaetsklinikum Schleswig Holstein | Lubeck | Germany | ||
| 57 | Universitätsklinikum Magdeburg | Magdeburg | Germany | ||
| 58 | Kardiologische Praxis | Markkleeberg | Germany | ||
| 59 | Dietrich Bonhoeffer Klinikum | Neubrandenburg | Germany | ||
| 60 | Universitatsklinikum | Wurzburg | Germany | ||
| 61 | Ospedale Garibaldi Centro | Catania | Italy | ||
| 62 | Ospedale Pol SS Annunziata | Chieti | Italy | ||
| 63 | Presidio Ospedaliero di Chioggia | Chioggia | Italy | ||
| 64 | Ospital San Luca | Lucca | Italy | ||
| 65 | Ospedale Civile | Mirano | Italy | ||
| 66 | Osp S Giovanni Bosco | Napoli | Italy | ||
| 67 | Ospedale Cardarelli | Napoli | Italy | ||
| 68 | Ospedale Policlinico Federico II | Napoli | Italy | ||
| 69 | Policlinico Casilino | Rome | Italy | ||
| 70 | Osp. G. Mazzini | Teramo | Italy | ||
| 71 | Azienda Ospedaliero-Universitaria Ospedali Riuniti | Trieste | Italy | ||
| 72 | Vlietland Ziekenhuis | Schiedam | Netherlands | ||
| 73 | Isala Klinieken | Zwolle | Netherlands | ||
| 74 | Hospital Garcia de Orta | Almada | Portugal | ||
| 75 | Hospital Professor Doutor Fernando Fonseca | Amadora | Portugal | ||
| 76 | CHLC Hospital de Santa Marta | Lisboa | Portugal | ||
| 77 | H. Santa Maria | Lisboa | Portugal | ||
| 78 | Susch Hospital | Banská Bystrica | Slovakia | ||
| 79 | Nusch Hospital | Bratislava | Slovakia | ||
| 80 | Vusch Hospital | Kosice | Slovakia | ||
| 81 | Hospital Clínic de Barcelona | Barcelona | Spain | ||
| 82 | Hospital Virgen de las Nieves | Granada | Spain | ||
| 83 | Hospital Ramon y Cajal | Madrid | Spain | ||
| 84 | Hospital Universitario Clínico San Carlos | Madrid | Spain | ||
| 85 | Hospital Universitario Puerta de Hierro | Majadahonda | Spain | ||
| 86 | Hospital Universitario Virgen de la Victoria | Malaga | Spain | ||
| 87 | Hospital Central de Asturias | Oviedo | Spain | ||
| 88 | Hospital Son Llàtzer | Palma de Mallorca | Spain | ||
| 89 | Complejo Hospitalario Universitario | Santiago de Compostela | Spain | ||
| 90 | H.U La Fe | Valencia | Spain | ||
| 91 | CHU de Vigo | Vigo | Spain | ||
| 92 | Fondazione Cardiocentro Ticino | Lugano | Switzerland | ||
| 93 | Barnet General Hospital | Barnet | United Kingdom | ||
| 94 | Edgbaston | Birmingham | United Kingdom | ||
| 95 | Papworth Hospital NHS Foundation Trust | Cambridge | United Kingdom | ||
| 96 | Dorget County Hospital | Dorchester | United Kingdom | ||
| 97 | Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | ||
| 98 | Wye Valley NHS Trust | Hereford | United Kingdom | ||
| 99 | Glenfield Hospital | Leicester | United Kingdom | ||
| 100 | King's College Hospital | London | United Kingdom | ||
| 101 | Northampton General Hospital | Northampton | United Kingdom | ||
| 102 | Northern General Hospital | Sheffield | United Kingdom |
Sponsors and Collaborators
- MicroPort CRM
Investigators
- Principal Investigator: Javier Moreno, Dr, Hospital Ramón y Cajal Ctra. de Colmenar Viejo km 9.100, 28034 Madrid, Spain
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RTSY03