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

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ClinicalTrials.gov Identifier: NCT02091011
Recruitment Status : Active, not recruiting
First Posted : March 19, 2014
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief 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)

Condition or disease
Implantable Cardioverter Defibrillators CRT-D Cardiac Resynchronization Therapy Defibrillator

Study Design
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Study Type : Observational
Actual Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices.
Actual Study Start Date : January 27, 2014
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 1, 2021
Groups and Cohorts
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Group/Cohort
Cohort group
Subjects who have been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091011


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Samir Saba, MD, FACC, FHRS University of Pittsburgh Medical Center
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02091011    
Other Study ID Numbers: PDM 90912475
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: June 2020
Keywords provided by Boston Scientific Corporation:
This study is designed to efficiently provide device and battery longevity data on market released
Boston Scientific ICD and CRT-D (Cardiac Resynchronization Therapy Defibrillator) devices. In addition, the data collected will allow for
comparisons of device survival probability estimated in the Product Performance Report versus
those collected in the study. The data collected will also provide a better understanding on the
potential predictors of pulse generator battery longevity.