LONGEVITY Study. Evaluation of the Device and Battery Lon... | NCT02091011

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

NCT02091011

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Aug 2, 2022Actual

Enrollment

1,600Actual

Phase

Not provided

Conditions

Implantable Cardioverter Defibrillators
CRT-D Cardiac Resynchronization Therapy Defibrillator

Interventions

Not provided

Countries

United States
Canada
Germany
Japan
South Korea
Spain
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2014Actual

Primary Completion Date

Aug 2021Actual

Completion Date

Aug 2021Actual

First Submitted Date

Mar 17, 2014

First Submission Date that Met QC Criteria

Mar 18, 2014

First Posted Date

Mar 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2022

Last Update Posted Date

Aug 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Conditions Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600Actual

Label	Type	Description	Intervention Names
Cohort group		Subjects who have been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Alabama cardiovascular group		Birmingham	Alabama	35205	United States
Birmingham Heart Clinic, P.C.

Type	Date	Date Unknown
Release	Aug 3, 2022
Reset	Jun 2, 2023