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LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices

NCT02091011 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2022-08-02

No results posted yet for this study

Summary

The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)

Conditions

  • Implantable Cardioverter Defibrillators
  • CRT-D Cardiac Resynchronization Therapy Defibrillator

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Samir Saba, MD, FACC, FHRS · University of Pittsburgh Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-27
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States
  • Canada
  • Germany
  • Japan
  • South Korea
  • 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 NCT02091011 on ClinicalTrials.gov