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

Implantable Cardioverter Defibrillators Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091011
• Other study ID #: PDM 90912475
• Status: Completed
• Start date: January 27, 2014
• Est. completion date: August 2021

Study information

• Verified date: July 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• CRT-D Cardiac Resynchronization Therapy Defibrillator
• Implantable Cardioverter Defibrillators

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Japan,  Korea, Republic of,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Evaluate potential predictors of device battery longevity at 5 years post-implantation.		5 years