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

NCT02091011 | Completed

• 1 other identifier: PDM 90912475
• Study Type: observational
• Target: 1,600
• Locations: 8 countries
• Sites: 80

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)

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.

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

Cohort group

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (80)

Alabama cardiovascular group

Birmingham, Alabama, 35205, United States

Location

Birmingham Heart Clinic, P.C.

Birmingham, Alabama, 35235, United States

Location

Phoenix Heart, PLLC

Glendale, Arizona, 85306, United States

Location

Pima Heart Physicians PC

Tucson, Arizona, 85712, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Mercy Clinic Cardiology Physician Plaza

Rogers, Arkansas, 72758, United States

Location

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Bradenton Cardiology Center

Bradenton, Florida, 34205, United States

Location

Jackson Memorial Hospital, JHS Office of Research

Miami, Florida, 33136, United States

Location

Florida Electrophysiology, LLC

Orlando, Florida, 32837, United States

Location

Bay Area Heart Center

St. Petersburg, Florida, 33709, United States

Location

Alexian Brothers

Elk Grove Village, Illinois, 60007, United States

Location

Franciscan Physician Network Cardiology Crown Point

Crown Point, Indiana, 46307, United States

Location

The Heart Group, PC

Newburgh, Indiana, 47630, United States

Location

InityPoint Health - St. Luke's Hospital

Cedar Rapids, Iowa, 52402, United States

Location

Advance Cardiovascular Specialists

Shreveport, Louisiana, 71105, United States

Location

Delmarva Heart Research Foundation, Inc., TidalHealth Peninsula Regional, Inc.

Salisbury, Maryland, 21804, United States

Location

Mass Heart and Rhythm

Leominster, Massachusetts, 01453, United States

Location

McLaren Bay

Bay City, Michigan, 48708, United States

Location

Hurley Medical Center

Flint, Michigan, 48532, United States

Location

Borgess Research Institute

Kalamazoo, Michigan, 49048, United States

Location

Great Lakes Heart And Vascular Institute

Saint Joseph, Michigan, 49085, United States

Location

Cardiovascular Clinic of Hattiesburg

Hattiesburg, Mississippi, 39402, United States

Location

Wesley Medical Center

Hattiesburg, Mississippi, 39402, United States

Location

Kansas City Heart Foundation

Kansas City, Missouri, 64114, United States

Location

PCRMC Medical Group

Rolla, Missouri, 65401, United States

Location

Gateway Cardiology

St Louis, Missouri, 63128, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

University Hospital, Newark

Newark, New Jersey, 07103, United States

Location

Stony Brook Community Medical, PC

East Setauket, New York, 11733, United States

Location

New York Hospital Queens

Flushing, New York, 11355, United States

Location

Westchester Heart & Vascular

Hawthorne, New York, 10532, United States

Location

Asheville Cardiology Associates

Asheville, North Carolina, 28803, United States

Location

St. Alexius Medical Center

Bismarck, North Dakota, 58501, United States

Location

Stark Medical Specialties

Massillon, Ohio, 44646, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Oregon Cardiology Sacred Heart at Riverbend Hospital

Springfield, Oregon, 97477, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Heart and Vascular Institute, University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Carolina Cardiology Assoc, Piedmont Medical Center

Rock Hill, South Carolina, 29732, United States

Location

Parkridge Medical Ctr.

Chattanooga, Tennessee, 37404, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Texas Heart Rhythm

Houston, Texas, 77074, United States

Location

Cardiology Clinic San Antonio

San Antonio, Texas, 78229, United States

Location

Central Utah Clinic

Provo, Utah, 84604, United States

Location

Cardiology Associates of Fredericksburg

Fredericksburg, Virginia, 22408, United States

Location

Carient Heart & Vasculare

Manassas, Virginia, 20109, United States

Location

CAMC Health Education and Research Institute

Charleston, West Virginia, 25301, United States

Location

Prevea Clinic, Inc.

Green Bay, Wisconsin, 54307-9070, United States

Location

Clinical Research Specialist, Research Institute ProHealth Care, Inc

Waukesha, Wisconsin, 53188, United States

Location

Cardiology Research Group Royal Alexandra Hospital

Edmonton, Alberta, T5H 3v9, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3M2, Canada

Location

Hospital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J IC5, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke, CHUS/CRC

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Charite Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Kardiologie und Angiologie

Kiel, 24105, Germany

Location

Chiba University Hospital

Chiba, Japan

Location

Fukuoka University Hospital

Fukuoka, 8140133, Japan

Location

University of Tsukuba Hospital

Ibaraki, 3058576, Japan

Location

Japan Labour Health and and Welfare Organization, Yokohama Rosai Hospital

Kanagawa-Prefecture, 222-003, Japan

Location

Saitama Medical University, Saitama Redcross Hospital

Saitama, 3388553, Japan

Location

Tokohu University Hospital

Sendai, 9808574, Japan

Location

Showa University Hospital

Tokyo, 142-8555, Japan

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Seoul National University Hospital

Seoul, 100-744, South Korea

Location

Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Seoul St. Mary Hospital

Seoul, 137-701, South Korea

Location

Sejong General Hospital

Seoul, 422-711, South Korea

Location

Seoul National University Bundang Hospital

Seoul, 463-707, South Korea

Location

Hospital Universitario de Cruces. Servicio de Cardiología

Barakaldo, 48903, Spain

Location

Hospital Universitario La Paz. Servicio de Cardiología. Sección de Arritmias. Planta primera diagonal

Madrid, 28046, Spain

Location

Hospital Universitario "Miguel Servet". Servicio de Cardiología

Zaragoza, 50009, Spain

Location

Universitatsspital Basel Klinik fur Kardiologie

Basel, 4031, Switzerland

Location

Kantonspital St Gallen, Klinik fur Kardiologie

Sankt Gallen, 9007, Switzerland

Location

Bristol Heart Institute

Bristol, BS28HW, United Kingdom

Location

St Bartholomew's Hospital, EP Cardiac Research Department, Barts Health NHS Trust

London, C1A 7BE, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

University Hospital of Southhampton

Southampton, SO16 6YD, United Kingdom

Location

Study Officials

• Samir Saba, MD, FACC, FHRS

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 19, 2014
• Study Start: January 27, 2014
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

US (51); CH (2); CA (4); DE (2); KR (7); ES (3); JP (7); GB (4)