NCT04118803

Observational Study on Inappropriate Therapies

Official Title:

Observational Study on Inappropriate Therapies After Replacement of ICDs

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)

Eligibility

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

Disease(s) and\or Condition(s)

Inappropriate Shocks From Implanted Defibrillator

ICD Replacement or Upgrade

Primary Purpose
Intervention/Treatment
    • Type: DEVICE
    • Name: ICD replacement or upgrade
    • Description: 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.
    • Arm Group Labels:
Sponsor
  • MicroPort CRM