Heart FailureLSRNCT00636272
Longitudinal Surveillance Registry
An observational study of Heart Failure and Sudden Cardiac Death, run by Boston Scientific Corporation.
Trial summary
Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators (PGs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Sudden Cardiac Death
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to not given
- 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: Patient who are or will be implanted with a LATITUDE-enabled pulse generator (ICD or CRT-D).
Who may be able to join
- Patient who is or is scheduled to be implanted within 30 days of signing the consent with a currently available BSC PG (lead systems may include other manufacturers' leads) that can be followed on the LATITUDE Patient Management system
- Patient who plans to remain in the long-term care of his/her enrolling physician (must be followed in-clinic at least once every 24 months by his/her enrolling physician)
- Patient who confirms that s/he has a telephone line compatible with the LATITUDE Patient Management system Communicator
- Patient or appropriate legal representative who is willing and capable of providing authorization for participation in the LSR
Who cannot join
- Patient who cannot be followed on the LATITUDE Patient Management system
- Patient who is unable or unwilling to comply with the protocol requirements
About this study
Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators (PGs).
Read the detailed description
The LSR is an active, prospective, non-randomized, multi-center registry of patients implanted with BSC commercially available LATITUDE-enabled products. The primary purpose of the LSR is to evaluate and report on the long-term reliability and clinical performance of BSC's commercially available PGs and leads using the LATITUDE Patient Management system to augment information collected from in-clinic visits. The LSR is designed to enroll patients implanted with BSC LATITUDE-enabled (wireless or wanded) commercially available PGs (lead systems may include other manufacturers' leads).
The primary objective of the LSR is to prospectively evaluate market-released PGs and leads to verify long-term system performance. The secondary objectives of the LSR include:
- To compare PG- and lead-related reliability data collected via LATITUDE with PG- and lead-related reliability data collected at in-clinic visits II. To compare this active surveillance of BSC PG and lead reliability data to the current passive surveillance system III. To enhance understanding of feature performance, patient management and clinical outcomes
- Conditions
- Heart Failure, Sudden Cardiac Death
- Keywords
- ICD, CRT-D
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boston Scientific, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636272
- Sponsor's protocol ID
- CR-CA-011608-T
- Acronym
- LSR
- Status last verified
- Aug 2008
- First submitted
- 7 Mar 2008
- Last updated
- 18 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Surveillance Registry
- ClinicalTrials.gov ID
- NCT00636272
- Acronym / sponsor ID
- LSR / CR-CA-011608-T
- Conditions
- Heart Failure, Sudden Cardiac Death
- Keywords
- ICD, CRT-D
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- First posted
- 14 Mar 2008 (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.
Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators (PGs).
Detailed description
The LSR is an active, prospective, non-randomized, multi-center registry of patients implanted with BSC commercially available LATITUDE-enabled products. The primary purpose of the LSR is to evaluate and report on the long-term reliability and clinical performance of BSC's commercially available PGs and leads using the LATITUDE Patient Management system to augment information collected from in-clinic visits. The LSR is designed to enroll patients implanted with BSC LATITUDE-enabled (wireless or wanded) commercially available PGs (lead systems may include other manufacturers' leads).
The primary objective of the LSR is to prospectively evaluate market-released PGs and leads to verify long-term system performance. The secondary objectives of the LSR include:
- To compare PG- and lead-related reliability data collected via LATITUDE with PG- and lead-related reliability data collected at in-clinic visits II. To compare this active surveillance of BSC PG and lead reliability data to the current passive surveillance system III. To enhance understanding of feature performance, patient management and clinical outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient who are or will be implanted with a LATITUDE-enabled pulse generator (ICD or CRT-D).
Key inclusion criteria (4 listed)
- Patient who is or is scheduled to be implanted within 30 days of signing the consent with a currently available BSC PG (lead systems may include other manufacturers' leads) that can be followed on the LATITUDE Patient Management system
- Patient who plans to remain in the long-term care of his/her enrolling physician (must be followed in-clinic at least once every 24 months by his/her enrolling physician)
- Patient who confirms that s/he has a telephone line compatible with the LATITUDE Patient Management system Communicator
- Patient or appropriate legal representative who is willing and capable of providing authorization for participation in the LSR
Key exclusion criteria (2 listed)
- Patient who cannot be followed on the LATITUDE Patient Management system
- Patient who is unable or unwilling to comply with the protocol requirements
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
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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.
Boston Scientific study director
Boston Scientific Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Sudden Cardiac Death, run by Boston Scientific Corporation.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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.
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 18 Aug 2008.