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Completed

NCT Number: NCT02091011

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

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)

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Key information

Conditions

Implantable Cardioverter Defibrillators CRT-D Cardiac Resynchronization Therapy Defibrillator

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Research Group Royal Alexandra Hospital, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device according to current guidelines and/or center's current practice
  • Subject is willing and capable (or appropriate legal representative is willing and capable) of authorizing access to and use of health information as required by an Institution's Institutional Review Board (IRB), Research Ethics Board (REB) or Ethics Committee (EC)
  • Is willing and capable (or appropriate legal representative is willing and capable) of providing authorization/consent for participation in the study.

Exclusion criteria

  • Subject is unable or unwilling to comply with the study protocol requirements
  • Subject is under the legal age for signing study consent in accordance with state or national law
  • Subject has a life expectancy of less than twelve months
  • Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician's discretion)
  • Subject on active heart transplant list
  • Subject with any prior pulse generator infection or lead infection which is either systemic or localized
  • Subject received a commercially available Boston Scientific ICD or CRT-D device with a battery capacity of 1.5 amp/hour or less
  • Subject implanted with Boston Scientific's subcutaneous implantable defibrillator system (s-ICD) or has a lead that is under recall/advisory at the time of enrollment

Treatment and study plan

Primary outcomes

  1. Determine the rate and cause of all-cause device replacements of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation.

    Time frame: 5 years

  2. Evaluate the battery survival of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation.

    Time frame: 5 years

    Battery survival is defined as freedom from surgical replacement of the device due to battery depletion.

Secondary outcomes

  1. Determine the rate and cause of all-cause device replacement of Boston Scientific's market-released ICD and CRT-D devices 1, 2, 3 and 4 years post-implantation.

    Time frame: 1, 2, 3, and 4 years

  2. Evaluate battery survival of Boston Scientific's market-released ICD and CRT-D devices at 1, 2, 3 and 4 years post-implantation.

    Time frame: 1, 2, 3, and 4 years

  3. Evaluate the device survival of Boston Scientific's market released ICD and CRT-D pulse generators at 5 years post-implantation; and compare it to the survival probability presented in the Product Performance Report (PPR).

    Time frame: 5 years

  4. Evaluate potential predictors of device battery longevity at 5 years post-implantation.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2014
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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