Observational Study on Inappropriate Therapies (OSIRIS)

June 2, 2023 updated by: MicroPort CRM

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

881

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Innsbruck, Austria
        • Universitätsklinik Innsbruck - Kardiologie und Angiologie
      • Vienna, Austria
        • Akademisches Krankenhaus Wien
      • Wiener Neustadt, Austria
        • Landesklinikum Wiener Neustadt
  • Belgium
      • Jette, Belgium
        • UZ Brussel
      • Yvoir, Belgium
        • UCL Mont-Godinne
  • France
      • Aix-en-Provence, France
        • CH du Pays d'Aix
      • Annecy, France
        • Ch Annecy Genevois
      • Avignon, France
        • Clinique Rhône Durance
      • Brest, France
        • CHU Brest
      • Clamart, France
        • Hôpital d'Instruction des Armées PERCY
      • Grenoble, France
        • CHU de Grenoble
      • Libourne, France
        • CH de Libourne Robert Boulin
      • Limoges, France
        • Chu Dupuytren
      • Marseille, France
        • Hopital Nord
      • Marseille, France
        • Hôpital privé Clairval
      • Montpellier, France
        • Clinique du Millénaire
      • Nice, France
        • CHU Nice
      • Nîmes, France
        • CHU Groupe HU Caremeau
      • Perpignan, France
        • CH de Perpignan CHG St Jean
      • Poitiers, France
        • CHU Poitiers
      • Saint-Étienne, France
        • CHU - Hôpital Nord - Saint-Étienne
      • Toulon, France
        • CHI Toulon La Seyne Sur Mer
      • Toulouse, France
        • Centre Hospitalier de Rangueil
      • Valence, France
        • Centre Hospitalier de Valence
  • Germany
      • Kiel, Germany
        • UKSH Schleswig Holstein Campus Kiel
      • Munich, Germany
        • Deutsches Herzzentrum München
      • Pirna, Germany
        • Cardiologicum
      • Unna, Germany
        • Katharinen Hospital Unna
  • Italy
      • Andria, Italy
        • Ospedale L. Bonomo
      • Avellino, Italy
        • Azienda Ospedaliera G. Moscati
      • Chieti, Italy
        • Ospedale Clinicizzato SS. Annunziata
      • Chioggia, Italy
        • Presidio Ospedaliero di Chioggia
      • Conegliano, Italy
        • Ospedale Santa Maria dei Battuti
      • L'Aquila, Italy
        • Ospedale San Salvatore
      • Milan, Italy
        • Grande Ospedale Metropolitano Niguarda Ca Granda
      • Monza, Italy
        • Ospedale S. Gerardo
      • Napoli, Italy
        • Ospedale Policlinico Federico II
      • Ragusa, Italy
        • Ospedale Giovanni Paolo II
      • Teramo, Italy
        • Ospedale Giuseppe Mazzini
      • Trieste, Italy
        • Azienda Ospedaliero Universitaria Ospedali Riuniti Di Trieste
  • Netherlands
      • Zwolle, Netherlands
        • Isala Klinieken
  • Portugal
      • Lisbon, Portugal
        • Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Alzira, Spain
        • Hospital Universitario de La Ribera
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves
      • Malaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain
        • Hospital General Universitario de Valencia
      • Vigo, Spain
        • Complejo Hospitalario Universitario de Vigo
  • Switzerland
      • Basel, Switzerland
        • Universitatsspital Basel
      • Wetzikon, Switzerland
        • GZO Spital Wetzikon AG
  • United Kingdom
      • Belfast, United Kingdom
        • Belfast Health & Social Care Trust
      • Cambridge, United Kingdom
        • Papworth Hospital NHS Foundation Trust
      • Northampton, United Kingdom
        • Northampton General Hospital NHS Trust
  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 years after replacement or upgrade

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

Investigators

  • Principal Investigator: Christoff Kolb, Dr., Deutsches Herzzentrum, Lazarettstraße 36, 80636 Munich, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2020

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

October 5, 2019

First Submitted That Met QC Criteria

October 5, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • RTSY04 - OSIRIS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A clinical study report will be completed at the end of the study and publication of study results may be performed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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