Observational Study on Inappropriate Therapies
OSIRIS
1 other identifier
observational
881
11 countries
58
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedStudy Start
First participant enrolled
January 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedJune 5, 2023
June 1, 2023
5.3 years
October 5, 2019
June 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
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
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).
You may qualify if:
- 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
- Signed and dated the informed consent form
You may not qualify if:
- RV lead replacement
- Previous ICD/CRT-D inactivated or already explanted
- Active myocarditis
- Primary prevention for Arrhythmogenic Ventricular Cardiomyopathy, Ion channelopathies, Hypertrophic Cardiomyopathy and Infiltrative or Inherited Cardiomyopathy.
- Heart transplant (done or on waiting list) or implanted with a ventricular assist device (VAD)
- Already included in an Interventional study that could confound the results of this study
- Inability to understand the purpose of the study or to meet follow-up visits as defined in the investigational plan
- Minor age (\<18 years) or under guardianship or kept in detention
- Ongoing drug or alcohol addiction or abuse which would interfere with the subject's ability to be compliant with the study.
- Life expectancy less than 1 year
- Pregnant or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MicroPort CRMlead
Study Sites (58)
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
The University of Chicago Medicine Hospital
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
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
Study Officials
- PRINCIPAL INVESTIGATOR
Christoff Kolb, Dr.
Deutsches Herzzentrum, Lazarettstraße 36, 80636 Munich, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2019
First Posted
October 8, 2019
Study Start
January 31, 2020
Primary Completion
May 30, 2025
Study Completion
May 30, 2025
Last Updated
June 5, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
A clinical study report will be completed at the end of the study and publication of study results may be performed