Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
881 participants
OBSERVATIONAL
2020-01-31
2025-05-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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ICD replacement or upgrade
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.
Eligibility Criteria
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Inclusion Criteria
2. Signed and dated the informed consent form
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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MicroPort CRM
INDUSTRY
Responsible Party
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Principal Investigators
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Christoff Kolb, Dr.
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum, Lazarettstraße 36, 80636 Munich, Germany
Locations
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Broward Health Medical Center
Fort Lauderdale, Florida, United States
The University of Chicago Medicine Hospital
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 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
Napoli, , 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
Countries
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Other Identifiers
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RTSY04 - OSIRIS
Identifier Type: -
Identifier Source: org_study_id
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