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The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)
All subjects will be included during an inclusion visit (within 7 days post generator replacement or upgrade), and followed up at a post replacement visit (1 - 6 months post replacement or upgrade), at 12, 18 and 24 months post replacement or upgrade. These follow-up visits will be performed in-clinic except for the 18 months post replacement or upgrade visit, which could be performed through device remote monitoring.
Additional follow-ups can be performed at physician's discretion. Data on reportable adverse events will be collected throughout the study. All study data will be collected using an EDC system.
All delivered anti-tachycardia therapies (shock or ATP) will be reviewed by an independent board of experts in order to evaluate appropriateness.
The programming of the device parameters is at physician's discretion (suggested settings is slow VT monitoring zone 150 - 185 bpm with 30 cycles persistence, VT zone 185 - 230 bpm with 16 cycles persistence, remote monitoring activated).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD replacement or upgrade | Device | Currently, it is common for patients to survive beyond their initial prophylactic ICD generator. It is unclear whether further benefit related to inappropriate shocks or ATP is derived from long-term device therapy, particularly if there has been a change in the patient's cardiovascular condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of inappropriate shocks | This endpoint will assess the incidence of inappropriate shocks, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR). | 2 years after replacement or upgrade |
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Inclusion Criteria:
Exclusion Criteria:
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Patients indicated for an ICD or CRT-D implant according to the latest applicable guidelines and requiring a device replacement or system upgrade from a previous ICD (VR/DR/CRT-D).
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| Name | Affiliation | Role |
|---|---|---|
| Christoff Kolb, Dr. | Deutsches Herzzentrum, Lazarettstraße 36, 80636 Munich, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States | ||
| The University of Chicago Medicine Hospital |
A clinical study report will be completed at the end of the study and publication of study results may be performed
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| Chicago |
| Illinois |
| 60637 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| St. Mary Medical Center | Langhorne | Pennsylvania | 19047 | United States |
| Universitätsklinik Innsbruck - Kardiologie und Angiologie | Innsbruck | Austria |
| Akademisches Krankenhaus Wien | Vienna | Austria |
| Landesklinikum Wiener Neustadt | Wiener Neustadt | Austria |
| UZ Brussel | Jette | Belgium |
| UCL Mont-Godinne | Yvoir | Belgium |
| CH du Pays d'Aix | Aix-en-Provence | France |
| CH Annecy Genevois | Annecy | France |
| Clinique Rhône Durance | Avignon | France |
| CHU Brest | Brest | France |
| Hôpital d'Instruction des Armées Percy | Clamart | France |
| CHU de Grenoble | Grenoble | France |
| CH de Libourne Robert Boulin | Libourne | France |
| CHU Dupuytren | Limoges | France |
| Hôpital Nord | Marseille | France |
| Hôpital Privé Clairval | Marseille | France |
| Clinique du Millénaire | Montpellier | France |
| CHU Nice | Nice | France |
| CHU Groupe HU Caremeau | Nîmes | France |
| CH de Perpignan CHG St Jean | Perpignan | France |
| CHU Poitiers | Poitiers | France |
| CHU - Hôpital Nord - Saint-Étienne | Saint-Etienne | France |
| CHI Toulon La Seyne Sur Mer | Toulon | France |
| Centre Hospitalier de Rangueil | Toulouse | France |
| Centre Hospitalier de Valence | Valence | France |
| UKSH Schleswig Holstein Campus Kiel | Kiel | Germany |
| Deutsches Herzzentrum München | Munich | Germany |
| Cardiologicum | Pirna | Germany |
| Katharinen Hospital Unna | Unna | Germany |
| Ospedale L. Bonomo | Andria | Italy |
| Azienda Ospedaliera G. Moscati | Avellino | Italy |
| Ospedale Clinicizzato SS. Annunziata | Chieti | Italy |
| Presidio Ospedaliero di Chioggia | Chioggia | Italy |
| Ospedale Santa Maria dei Battuti | Conegliano | Italy |
| Ospedale San Salvatore | L’Aquila | Italy |
| Grande Ospedale Metropolitano Niguarda Ca Granda | Milan | Italy |
| Ospedale S. Gerardo | Monza | Italy |
| Ospedale Policlinico Federico II | Naples | Italy |
| Ospedale Giovanni Paolo II | Ragusa | Italy |
| Ospedale Giuseppe Mazzini | Teramo | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Di Trieste | Trieste | Italy |
| Isala Klinieken | Zwolle | Netherlands |
| Centro Hospitalar Lisboa Norte - Hospital de Santa Maria | Lisbon | Portugal |
| Hospital General Universitario de Alicante | Alicante | Spain |
| Hospital Universitario de La Ribera | Alzira | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain |
| Hospital General Universitario de Valencia | Valencia | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Spain |
| Universitätsspital Basel | Basel | Switzerland |
| GZO Spital Wetzikon AG | Wetzikon | Switzerland |
| Belfast Health & Social Care Trust | Belfast | United Kingdom |
| Papworth Hospital NHS Foundation Trust | Cambridge | United Kingdom |
| Northampton General Hospital NHS TRUST | Northampton | United Kingdom |