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Observational Study on Inappropriate Therapies

NCT04118803 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 881

Last updated 2023-06-05

No results posted yet for this study

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)

Conditions

  • Inappropriate Shocks From Implanted Defibrillator
  • ICD Replacement or Upgrade

Interventions

DEVICE

ICD replacement or upgrade

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.

Sponsors & Collaborators

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Christoff Kolb, Dr. · Deutsches Herzzentrum, Lazarettstraße 36, 80636 Munich, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118803 on ClinicalTrials.gov