Inappropriate Shocks From Implanted DefibrillatorOSIRISNCT04118803
Observational Study on Inappropriate Therapies
An observational study of Inappropriate Shocks From Implanted Defibrillator and ICD Replacement or Upgrade, run by MicroPort CRM at 58 sites in 11 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inappropriate Shocks From Implanted Defibrillator, ICD Replacement or Upgrade
- What is being tested?
- ICD replacement or upgrade
- Type of treatment
- Medical device
- How many people
- 881 participants
- Where
- 58 sitesin 11 countries
- Study dates
- 31 Jan 2020to 30 May 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
58 sites in 11 countries.
58 sites in 11 countries
France19 sites
CH du Pays d'Aix
Aix-en-Provence
CH Annecy Genevois
Annecy
Clinique Rhône Durance
Avignon
CHU Brest
Brest
Hôpital d'Instruction des Armées Percy
Clamart
CHU de Grenoble
Grenoble
CH de Libourne Robert Boulin
Libourne
CHU Dupuytren
Limoges
Hôpital Nord
Marseille
Hôpital Privé Clairval
Marseille
Clinique du Millénaire
Montpellier
CHU Nice
Nice
CHU Groupe HU Caremeau
Nîmes
CH de Perpignan CHG St Jean
Perpignan
CHU Poitiers
Poitiers
CHU - Hôpital Nord - Saint-Étienne
Saint-Etienne
CHI Toulon La Seyne Sur Mer
Toulon
Centre Hospitalier de Rangueil
Toulouse
Centre Hospitalier de Valence
Valence
Italy12 sites
Ospedale L. Bonomo
Andria
Azienda Ospedaliera G. Moscati
Avellino
Ospedale Clinicizzato SS. Annunziata
Chieti
Presidio Ospedaliero di Chioggia
Chioggia
Ospedale Santa Maria dei Battuti
Conegliano
Ospedale San Salvatore
L’Aquila
Grande Ospedale Metropolitano Niguarda Ca Granda
Milan
Ospedale S. Gerardo
Monza
Ospedale Policlinico Federico II
Naples
Ospedale Giovanni Paolo II
Ragusa
Ospedale Giuseppe Mazzini
Teramo
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Trieste
Trieste
Spain6 sites
Hospital General Universitario de Alicante
Alicante
Hospital Universitario de La Ribera
Alzira
Hospital Universitario Virgen de las Nieves
Granada
Hospital Universitario Virgen de la Victoria
Málaga
Hospital General Universitario de Valencia
Valencia
Complejo Hospitalario Universitario de Vigo
Vigo
United States5 sites
The University of Chicago Medicine Hospital
Chicago, Illinois, 60637
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
Loyola University Medical Center
Maywood, Illinois, 60153
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Germany4 sites
UKSH Schleswig Holstein Campus Kiel
Kiel
Deutsches Herzzentrum München
Munich
Cardiologicum
Pirna
Katharinen Hospital Unna
Unna
Austria3 sites
Universitätsklinik Innsbruck - Kardiologie und Angiologie
Innsbruck
Akademisches Krankenhaus Wien
Vienna
Landesklinikum Wiener Neustadt
Wiener Neustadt
United Kingdom3 sites
Belfast Health & Social Care Trust
Belfast
Papworth Hospital NHS Foundation Trust
Cambridge
Northampton General Hospital NHS TRUST
Northampton
Switzerland2 sites
Universitätsspital Basel
Basel
GZO Spital Wetzikon AG
Wetzikon
Portugal1 site
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
Lisbon
About this study
Official title: Observational Study on Inappropriate Therapies After Replacement of ICDs
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)
Read the detailed description
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).
- Being tested
- ICD replacement or upgrade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD replacement or upgradeDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years after replacement or upgrade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start31 Jan 2020
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate Shocks From Implanted DefibrillatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 881 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoff Kolb, Dr., Principal investigator, Deutsches Herzzentrum, Lazarettstraße 36, 80636 Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118803
- Sponsor's protocol ID
- RTSY04 - OSIRIS
- Acronym
- OSIRIS
- Status last verified
- Jun 2023
- First submitted
- 5 Oct 2019
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A clinical study report will be completed at the end of the study and publication of study results may be performed
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Inappropriate Therapies After Replacement of ICDs
- ClinicalTrials.gov ID
- NCT04118803
- Acronym / sponsor ID
- OSIRIS / RTSY04 - OSIRIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 881 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD replacement or upgradeCurrently, 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. | Device | – |
Primary outcome
Incidence of inappropriate shocks
Time frame: 2 years after replacement or upgrade
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No. A clinical study report will be completed at the end of the study and publication of study results may be performed
Related trials for Inappropriate Shocks From Implanted Defibrillator
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Subcutaneous ICD, Myopotential Interference
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoff Kolb, Dr. principal investigator
Deutsches Herzzentrum, Lazarettstraße 36, 80636 Munich, Germany
58 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inappropriate Shocks From Implanted Defibrillator and ICD Replacement or Upgrade, run by MicroPort CRM at 58 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in France, Italy, Spain, United States, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of inappropriate shocks (time frame: 2 years after replacement or upgrade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.