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

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)

Study Overview

• Status: Completed
• Conditions: Implantable Cardioverter Defibrillators; CRT-D Cardiac Resynchronization Therapy Defibrillator

• Study Type: Observational
• Enrollment (Actual): 1600

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3v9
      • Cardiology Research Group Royal Alexandra Hospital
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3M2
      • Royal Columbian Hospital
  • Quebec
    • Montreal, Quebec, Canada, H4J IC5
      • Hospital du Sacre-Coeur de Montreal
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke, CHUS/CRC
• Germany
  • Berlin, Germany, 13353
    • Charite Campus Virchow Klinikum
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein, Klinik für Kardiologie und Angiologie
• Japan
  • Chiba, Japan
    • Chiba University Hospital
  • Fukuoka, Japan, 8140133
    • Fukuoka University Hospital
  • Ibaraki, Japan, 3058576
    • University of Tsukuba Hospital
  • Kanagawa-Prefecture, Japan, 222-003
    • Japan Labour Health and and Welfare Organization, Yokohama Rosai Hospital
  • Saitama, Japan, 3388553
    • Saitama Medical University, Saitama Redcross Hospital
  • Sendai, Japan, 9808574
    • Tokohu University Hospital
  • Tokyo, Japan, 142-8555
    • Showa University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University Health System
  • Seoul, Korea, Republic of, 100-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 137-701
    • Seoul St. Mary Hospital
  • Seoul, Korea, Republic of, 422-711
    • Sejong General Hospital
• Spain
  • Barakaldo, Spain, 48903
    • Hospital Universitario de Cruces. Servicio de Cardiología
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz. Servicio de Cardiología. Sección de Arritmias. Planta primera diagonal
  • Zaragoza, Spain, 50009
    • Hospital Universitario "Miguel Servet". Servicio de Cardiología
• Switzerland
  • Basel, Switzerland, 4031
    • Universitatsspital Basel Klinik fur Kardiologie
  • St. Gallen, Switzerland, 9007
    • Kantonspital St Gallen, Klinik fur Kardiologie
• United Kingdom
  • Bristol, United Kingdom, BS28HW
    • Bristol Heart Institute
  • London, United Kingdom, C1A 7BE
    • St Bartholomew's Hospital, EP Cardiac Research Department, Barts Health NHS Trust
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook University Hospital
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital of Southhampton
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Cardiovascular Group
    • Birmingham, Alabama, United States, 35235
      • Birmingham Heart Clinic, P.C.
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Phoenix Heart, PLLC
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Health Care System
    • Tucson, Arizona, United States, 85712
      • Pima Heart Physicians PC
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Mercy Clinic Cardiology Physician Plaza
  • California
    • Loma Linda, California, United States, 92357
      • VA Loma Linda Healthcare System
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology Center
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital, JHS Office of Research
    • Orlando, Florida, United States, 32837
      • Florida Electrophysiology, LLC
    • Saint Petersburg, Florida, United States, 33709
      • Bay Area Heart Center
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers
  • Indiana
    • Crown Point, Indiana, United States, 46307
      • Franciscan Physician Network Cardiology Crown Point
    • Newburgh, Indiana, United States, 47630
      • The Heart Group, PC
  • Iowa
    • Cedar Rapids, Iowa, United States, 52402
      • InityPoint Health - St. Luke's Hospital
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Advance Cardiovascular Specialists
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Delmarva Heart Research Foundation, Inc., TidalHealth Peninsula Regional, Inc.
  • Massachusetts
    • Leominster, Massachusetts, United States, 01453
      • Mass Heart and Rhythm
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Bay
    • Flint, Michigan, United States, 48532
      • Hurley Medical Center
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Research Institute
    • Saint Joseph, Michigan, United States, 49085
      • Great Lakes Heart and Vascular Institute
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • Cardiovascular Clinic of Hattiesburg
    • Hattiesburg, Mississippi, United States, 39402
      • Wesley Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Kansas City Heart Foundation
    • Rolla, Missouri, United States, 65401
      • PCRMC Medical Group
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart and Vascular
    • Saint Louis, Missouri, United States, 63128
      • Gateway Cardiology
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • University Hospital, Newark
  • New York
    • East Setauket, New York, United States, 11733
      • Stony Brook Community Medical, PC
    • Flushing, New York, United States, 11355
      • New York Hospital Queens
    • Hawthorne, New York, United States, 10532
      • Westchester Heart & Vascular
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Cardiology Associates
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • St. Alexius Medical Center
  • Ohio
    • Massillon, Ohio, United States, 44646
      • Stark Medical Specialties
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • INTEGRIS Baptist Medical Center
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Cardiology Sacred Heart at Riverbend Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15213
      • Heart and Vascular Institute, University of Pittsburgh Medical Center
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Cardiology Assoc, Piedmont Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Parkridge Medical Ctr.
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • Houston, Texas, United States, 77074
      • Texas Heart Rhythm
    • San Antonio, Texas, United States, 78229
      • Cardiology Clinic San Antonio
  • Utah
    • Provo, Utah, United States, 84604
      • Central Utah Clinic
  • Virginia
    • Fredericksburg, Virginia, United States, 22408
      • Cardiology Associates of Fredericksburg
    • Manassas, Virginia, United States, 20109
      • Carient Heart & Vasculare
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • CAMC Health Education and Research Institute
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54307-9070
      • Prevea Clinic, Inc.
    • Waukesha, Wisconsin, United States, 53188
      • Clinical Research Specialist, Research Institute ProHealth Care, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort group; Subjects who have been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		5 years
Evaluate the battery survival of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation.	Battery survival is defined as freedom from surgical replacement of the device due to battery depletion.	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	1, 2, 3, and 4 years
Evaluate battery survival of Boston Scientific's market-released ICD and CRT-D devices at 1, 2, 3 and 4 years post-implantation.	1, 2, 3, and 4 years
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).	5 years
Evaluate potential predictors of device battery longevity at 5 years post-implantation.	5 years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Samir Saba, MD, FACC, FHRS, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2014
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 30, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: 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.
• Other Study ID Numbers: PDM 90912475