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

Completed

Conditions studied: Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator

In brief

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)

Key facts

Study ID

NCT02091011

Run by

Boston Scientific Corporation

People needed

1600

Starts

2014-01-27

Expected to finish

2021-08-01

Last updated by the study team

2022-08-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Birmingham Heart Clinic, P.C. — Birmingham, Alabama, United States
• Phoenix Heart, PLLC — Glendale, Arizona, United States
• Pima Heart Physicians PC — Tucson, Arizona, United States
• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• Mercy Clinic Cardiology Physician Plaza — Rogers, Arkansas, United States
• VA Loma Linda Healthcare System — Loma Linda, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Bradenton Cardiology Center — Bradenton, Florida, United States
• Jackson Memorial Hospital, JHS Office of Research — Miami, Florida, United States
• Florida Electrophysiology, LLC — Orlando, Florida, United States
• Bay Area Heart Center — St. Petersburg, Florida, United States
• Alexian Brothers — Elk Grove Village, Illinois, United States
• Franciscan Physician Network Cardiology Crown Point — Crown Point, Indiana, United States
• The Heart Group, PC — Newburgh, Indiana, United States
• InityPoint Health - St. Luke's Hospital — Cedar Rapids, Iowa, United States
• Advance Cardiovascular Specialists — Shreveport, Louisiana, United States
• Delmarva Heart Research Foundation, Inc., TidalHealth Peninsula Regional, Inc. — Salisbury, Maryland, United States
• Mass Heart and Rhythm — Leominster, Massachusetts, United States
• McLaren Bay — Bay City, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• Borgess Research Institute — Kalamazoo, Michigan, United States
• Great Lakes Heart And Vascular Institute — Saint Joseph, Michigan, United States
• Cardiovascular Clinic of Hattiesburg — Hattiesburg, Mississippi, United States
• Wesley Medical Center — Hattiesburg, Mississippi, United States
• Alabama cardiovascular group — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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