Clinical trial NCT02091011: LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
Official title: LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implantable Cardioverter Defibrillators
CRT-D Cardiac Resynchronization Therapy Defibrillator
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.
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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)


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 5 years
measure: Evaluate the battery survival of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation.
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 1, 2, 3, and 4 years
measure: Evaluate battery survival of Boston Scientific's market-released ICD and CRT-D devices at 1, 2, 3 and 4 years post-implantation.
timeFrame: 1, 2, 3, and 4 years
measure: 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).
timeFrame: 5 years
measure: Evaluate potential predictors of device battery longevity at 5 years post-implantation.
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama cardiovascular group
state: Alabama
city: Birmingham
country: United States
facility: Birmingham Heart Clinic, P.C.
state: Alabama
city: Glendale
country: United States
facility: Phoenix Heart, PLLC
state: Arizona
city: Tucson
country: United States
facility: Pima Heart Physicians PC
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Rogers
country: United States
facility: Mercy Clinic Cardiology Physician Plaza
state: Arkansas
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Bradenton Cardiology Center
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital, JHS Office of Research
state: Florida
city: Orlando
country: United States
facility: Florida Electrophysiology, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Bay Area Heart Center
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers
state: Illinois
city: Crown Point
country: United States
facility: Franciscan Physician Network Cardiology Crown Point
state: Indiana
city: Newburgh
country: United States
facility: The Heart Group, PC
state: Indiana
city: Cedar Rapids
country: United States
facility: InityPoint Health - St. Luke's Hospital
state: Iowa
city: Shreveport
country: United States
facility: Advance Cardiovascular Specialists
state: Louisiana
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation, Inc., TidalHealth Peninsula Regional, Inc.
state: Maryland
city: Leominster
country: United States
facility: Mass Heart and Rhythm
state: Massachusetts
city: Bay City
country: United States
facility: McLaren Bay
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Saint Joseph
country: United States
facility: Great Lakes Heart And Vascular Institute
state: Michigan
city: Hattiesburg
country: United States
facility: Cardiovascular Clinic of Hattiesburg
state: Mississippi
city: Hattiesburg
country: United States
facility: Wesley Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Heart Foundation
state: Missouri
city: Rolla
country: United States
facility: PCRMC Medical Group
state: Missouri
city: Saint Louis
country: United States
facility: Gateway Cardiology
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Newark
country: United States
facility: University Hospital, Newark
state: New Jersey
city: East Setauket
country: United States
facility: Stony Brook Community Medical, PC
state: New York
city: Flushing
country: United States
facility: New York Hospital Queens
state: New York
city: Hawthorne
country: United States
facility: Westchester Heart & Vascular
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Bismarck
country: United States
facility: St. Alexius Medical Center
state: North Dakota
city: Massillon
country: United States
facility: Stark Medical Specialties
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Springfield
country: United States
facility: Oregon Cardiology Sacred Heart at Riverbend Hospital
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Heart and Vascular Institute, University of Pittsburgh Medical Center
state: Pennsylvania
city: Rock Hill
country: United States
facility: Carolina Cardiology Assoc, Piedmont Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Parkridge Medical Ctr.
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: Texas Heart Rhythm
state: Texas
city: San Antonio
country: United States
facility: Cardiology Clinic San Antonio
state: Texas
city: Provo
country: United States
facility: Central Utah Clinic
state: Utah
city: Fredericksburg
country: United States
facility: Cardiology Associates of Fredericksburg
state: Virginia
city: Manassas
country: United States
facility: Carient Heart & Vasculare
state: Virginia
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute
state: West Virginia
city: Green Bay
country: United States
facility: Prevea Clinic, Inc.
state: Wisconsin
city: Waukesha
country: United States
facility: Clinical Research Specialist, Research Institute ProHealth Care, Inc
state: Wisconsin
city: Edmonton
country: Canada
facility: Cardiology Research Group Royal Alexandra Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Montreal
country: Canada
facility: Hospital du Sacre-Coeur de Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke, CHUS/CRC
state: Quebec
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Kardiologie und Angiologie
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Kanagawa-Prefecture
country: Japan
facility: Japan Labour Health and and Welfare Organization, Yokohama Rosai Hospital
city: Saitama
country: Japan
facility: Saitama Medical University, Saitama Redcross Hospital
city: Sendai
country: Japan
facility: Tokohu University Hospital
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Sejong General Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces. Servicio de Cardiología
city: Madrid
country: Spain
facility: Hospital Universitario La Paz. Servicio de Cardiología. Sección de Arritmias. Planta primera diagonal
city: Zaragoza
country: Spain
facility: Hospital Universitario "Miguel Servet". Servicio de Cardiología
city: Basel
country: Switzerland
facility: Universitatsspital Basel Klinik fur Kardiologie
city: St. Gallen
country: Switzerland
facility: Kantonspital St Gallen, Klinik fur Kardiologie
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: London
country: United Kingdom
facility: St Bartholomew's Hospital, EP Cardiac Research Department, Barts Health NHS Trust
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Southampton
country: United Kingdom
facility: University Hospital of Southhampton
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Samir Saba, MD, FACC, FHRS
role: PRINCIPAL_INVESTIGATOR
References: