Implantable Cardioverter DefibrillatorsNCT02091011
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
An observational study of Implantable Cardioverter Defibrillators and CRT-D Cardiac Resynchronization Therapy Defibrillator, run by Boston Scientific Corporation at 80 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
- How many people
- 1,600 participants
- Where
- 80 sitesin 8 countries
- Study dates
- 27 Jan 2014to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
80 sites in 8 countries.
80 sites in 8 countries
United States51 sites
Asheville Cardiology Associates
Asheville, North Carolina, 28803
McLaren Bay
Bay City, Michigan, 48708
Alabama cardiovascular group
Birmingham, Alabama, 35205
Birmingham Heart Clinic, P.C.
Birmingham, Alabama, 35235
St. Alexius Medical Center
Bismarck, North Dakota, 58501
Bradenton Cardiology Center
Bradenton, Florida, 34205
InityPoint Health - St. Luke's Hospital
Cedar Rapids, Iowa, 52402
CAMC Health Education and Research Institute
Charleston, West Virginia, 25301
Parkridge Medical Ctr.
Chattanooga, Tennessee, 37404
Franciscan Physician Network Cardiology Crown Point
Crown Point, Indiana, 46307
Stony Brook Community Medical, PC
East Setauket, New York, 11733
Alexian Brothers
Elk Grove Village, Illinois, 60007
Hurley Medical Center
Flint, Michigan, 48532
New York Hospital Queens
Flushing, New York, 11355
Cardiology Associates of Fredericksburg
Fredericksburg, Virginia, 22408
Phoenix Heart, PLLC
Glendale, Arizona, 85306
Prevea Clinic, Inc.
Green Bay, Wisconsin, 54307-9070
Cardiovascular Clinic of Hattiesburg
Hattiesburg, Mississippi, 39402
Wesley Medical Center
Hattiesburg, Mississippi, 39402
Westchester Heart & Vascular
Hawthorne, New York, 10532
Texas Heart Rhythm
Houston, Texas, 77074
Borgess Research Institute
Kalamazoo, Michigan, 49048
Kansas City Heart Foundation
Kansas City, Missouri, 64114
Mass Heart and Rhythm
Leominster, Massachusetts, 01453
VA Loma Linda Healthcare System
Loma Linda, California, 92357
Carient Heart & Vasculare
Manassas, Virginia, 20109
Stark Medical Specialties
Massillon, Ohio, 44646
Jackson Memorial Hospital, JHS Office of Research
Miami, Florida, 33136
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
University Hospital, Newark
Newark, New Jersey, 07103
The Heart Group, PC
Newburgh, Indiana, 47630
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Florida Electrophysiology, LLC
Orlando, Florida, 32837
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Heart and Vascular Institute, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Central Utah Clinic
Provo, Utah, 84604
Carolina Cardiology Assoc, Piedmont Medical Center
Rock Hill, South Carolina, 29732
Mercy Clinic Cardiology Physician Plaza
Rogers, Arkansas, 72758
PCRMC Medical Group
Rolla, Missouri, 65401
Great Lakes Heart And Vascular Institute
Saint Joseph, Michigan, 49085
Delmarva Heart Research Foundation, Inc., TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21804
Cardiology Clinic San Antonio
San Antonio, Texas, 78229
Advance Cardiovascular Specialists
Shreveport, Louisiana, 71105
Oregon Cardiology Sacred Heart at Riverbend Hospital
Springfield, Oregon, 97477
Gateway Cardiology
St Louis, Missouri, 63128
St. Louis Heart and Vascular
St Louis, Missouri, 63136
Bay Area Heart Center
St. Petersburg, Florida, 33709
Pima Heart Physicians PC
Tucson, Arizona, 85712
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Clinical Research Specialist, Research Institute ProHealth Care, Inc
Waukesha, Wisconsin, 53188
Japan7 sites
Chiba University Hospital
Chiba
Fukuoka University Hospital
Fukuoka, 8140133
University of Tsukuba Hospital
Ibaraki, 3058576
Japan Labour Health and and Welfare Organization, Yokohama Rosai Hospital
Kanagawa-Prefecture, 222-003
Saitama Medical University, Saitama Redcross Hospital
Saitama, 3388553
Tokohu University Hospital
Sendai, 9808574
Showa University Hospital
Tokyo, 142-8555
South Korea7 sites
Keimyung University Dongsan Medical Center
Daegu, 700-712
Seoul National University Hospital
Seoul, 100-744
Yonsei University Health System
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Seoul St. Mary Hospital
Seoul, 137-701
Sejong General Hospital
Seoul, 422-711
Seoul National University Bundang Hospital
Seoul, 463-707
Canada4 sites
Cardiology Research Group Royal Alexandra Hospital
Edmonton, Alberta, T5H 3v9
Hospital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J IC5
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3M2
Centre Hospitalier Universitaire de Sherbrooke, CHUS/CRC
Sherbrooke, Quebec, J1H 5N4
United Kingdom4 sites
Bristol Heart Institute
Bristol, BS28HW
St Bartholomew's Hospital, EP Cardiac Research Department, Barts Health NHS Trust
London, C1A 7BE
James Cook University Hospital
Middlesbrough, TS4 3BW
University Hospital of Southhampton
Southampton, SO16 6YD
Spain3 sites
Hospital Universitario de Cruces. Servicio de Cardiología
Barakaldo, 48903
Hospital Universitario La Paz. Servicio de Cardiología. Sección de Arritmias. Planta primera diagonal
Madrid, 28046
Hospital Universitario "Miguel Servet". Servicio de Cardiología
Zaragoza, 50009
Germany2 sites
Charite Campus Virchow Klinikum
Berlin, 13353
Universitätsklinikum Schleswig-Holstein, Klinik für Kardiologie und Angiologie
Kiel, 24105
Switzerland2 sites
Universitatsspital Basel Klinik fur Kardiologie
Basel, 4031
Kantonspital St Gallen, Klinik fur Kardiologie
Sankt Gallen, 9007
About this study
Official title: 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)
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort group | Subjects who have been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 5 years
Evaluate potential predictors of device battery longevity at 5 years post-implantation.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study start27 Jan 2014
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Cardioverter DefibrillatorsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samir Saba, MD, FACC, FHRS, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091011
- Sponsor's protocol ID
- PDM 90912475
- Status last verified
- Jul 2022
- First submitted
- 17 Mar 2014
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices.
- ClinicalTrials.gov ID
- NCT02091011
- Acronym / sponsor ID
- PDM 90912475
- 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.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2014 (actual)
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort group | – | –Subjects who have been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 5 years
Evaluate the battery survival of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation.
Time frame: 5 years
Battery survival is defined as freedom from surgical replacement of the device due to battery depletion.
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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).
Time frame: 5 years
Evaluate potential predictors of device battery longevity at 5 years post-implantation.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Saba, MD, FACC, FHRS principal investigator
University of Pittsburgh Medical Center
80 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Cardioverter Defibrillators and CRT-D Cardiac Resynchronization Therapy Defibrillator, run by Boston Scientific Corporation at 80 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Japan, South Korea, Canada, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.