ICD Replacement or Upgrade Clinical Trial
— OSIRISOfficial title:
Observational Study on Inappropriate Therapies After Replacement of ICDs
| Verified date | June 2023 |
| Source | MicroPort CRM |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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)
| Status | Active, not recruiting |
| Enrollment | 881 |
| Est. completion date | May 30, 2025 |
| Est. primary completion date | May 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Any subject that had an ICD/CRT-D replacement/upgrade according to the latest relevant clinical guidelines with a MicroPort CRM ICD / CRT-D for less than 7 days 2. Signed and dated the informed consent form Exclusion Criteria: 1. RV lead replacement 2. Previous ICD/CRT-D inactivated or already explanted 3. Active myocarditis 4. Primary prevention for Arrhythmogenic Ventricular Cardiomyopathy, Ion channelopathies, Hypertrophic Cardiomyopathy and Infiltrative or Inherited Cardiomyopathy. 5. Heart transplant (done or on waiting list) or implanted with a ventricular assist device (VAD) 6. Already included in an Interventional study that could confound the results of this study 7. Inability to understand the purpose of the study or to meet follow-up visits as defined in the investigational plan 8. Minor age (<18 years) or under guardianship or kept in detention 9. Ongoing drug or alcohol addiction or abuse which would interfere with the subject's ability to be compliant with the study. 10. Life expectancy less than 1 year 11. Pregnant or breast feeding |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Universitätsklinik Innsbruck - Kardiologie und Angiologie | Innsbruck | |
| Austria | Akademisches Krankenhaus Wien | Vienna | |
| Austria | Landesklinikum Wiener Neustadt | Wiener Neustadt | |
| Belgium | UZ Brussel | Jette | |
| Belgium | UCL Mont-Godinne | Yvoir | |
| France | 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-Étienne | |
| France | CHI Toulon La Seyne Sur Mer | Toulon | |
| France | Centre Hospitalier de Rangueil | Toulouse | |
| France | Centre Hospitalier de Valence | Valence | |
| Germany | UKSH Schleswig Holstein Campus Kiel | Kiel | |
| Germany | Deutsches Herzzentrum München | Munich | |
| Germany | Cardiologicum | Pirna | |
| Germany | Katharinen Hospital Unna | Unna | |
| Italy | 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 | Napoli | |
| Italy | Ospedale Giovanni Paolo II | Ragusa | |
| Italy | Ospedale Giuseppe Mazzini | Teramo | |
| Italy | Azienda Ospedaliero Universitaria Ospedali Riuniti Di Trieste | Trieste | |
| Netherlands | Isala Klinieken | Zwolle | |
| Portugal | Centro Hospitalar Lisboa Norte - Hospital de Santa Maria | Lisbon | |
| Spain | 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 | Malaga | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Spain | Complejo Hospitalario Universitario de Vigo | Vigo | |
| Switzerland | Universitätsspital Basel | Basel | |
| Switzerland | GZO Spital Wetzikon AG | Wetzikon | |
| United Kingdom | Belfast Health & Social Care Trust | Belfast | |
| United Kingdom | Papworth Hospital NHS Foundation Trust | Cambridge | |
| United Kingdom | Northampton General Hospital NHS TRUST | Northampton | |
| United States | The University of Chicago Medicine Hospital | Chicago | Illinois |
| United States | Broward Health Medical Center | Fort Lauderdale | Florida |
| United States | St. Mary Medical Center | Langhorne | Pennsylvania |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Rutgers New Jersey Medical School | Newark | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| MicroPort CRM |
United States, Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |