Observational Study on Inappropriate Therapies

Status unconfirmed

Conditions studied: Inappropriate Shocks From Implanted Defibrillator, ICD Replacement or Upgrade

In brief

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)

Key facts

Study ID

NCT04118803

Run by

MicroPort CRM

People needed

881

Starts

2020-01-31

Expected to finish

2025-05-30

Last updated by the study team

2023-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Broward Health Medical Center — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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