Status:
UNKNOWN
Observational Study on Inappropriate Therapies
Lead Sponsor:
MicroPort CRM
Conditions:
Inappropriate Shocks From Implanted Defibrillator
ICD Replacement or Upgrade
Eligibility:
All Genders
18+ years
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 implante...
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), a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
881 Patients enrolled
Trial Details
Trial ID
NCT04118803
Start Date
January 31 2020
End Date
May 30 2025
Last Update
June 5 2023
Active Locations (58)
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1
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
2
The University of Chicago Medicine Hospital
Chicago, Illinois, United States, 60637
3
Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103