ShockRVLIANCT00824915
Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)
An observational study of Shock, run by Medtronic.
Trial summary
The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA) upon commercial release. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Shock
- How many people
- 1,779 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Feb 2011
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with a confirmed Lead Integrity Algorithm download with a device download within the open and closed date of data collection
Who may be able to join
- Lead Integrity Algorithm download; requires a Medtronic device that supports the LIA algorithm; requires an RV lead; selected as part of the identified cohort
Who cannot join
- A device that does not support the Lead Integrity Algorithm,
About this study
The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA) upon commercial release.
- Conditions
- Shock
- Keywords
- Lead Integrity Algorithm
- Medical subject headings
- Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the LIA algorithm
Measured: 2 years
Positive predictive value of the LIA algorithm
Measured: 2 years
Number of false positives per patient-year of the LIA algorithm
Measured: 2 years
Reduction in the percent of patients with the LIA algorithm with an RV lead fracture who receive at least one inappropriate shock
Measured: Event driven (analysis requires 50 events)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startAug 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by MedtronicThe 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
- 1,779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- RVLIA Trial Leader, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824915
- Sponsor's protocol ID
- MDT1623319
- Acronym
- RVLIA
- Status last verified
- Feb 2018
- First submitted
- 16 Jan 2009
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)
- ClinicalTrials.gov ID
- NCT00824915
- Acronym / sponsor ID
- RVLIA / MDT1623319
- Conditions
- Shock
- Keywords
- Lead Integrity Algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,779 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 19 Jan 2009 (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 purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA) upon commercial release.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a confirmed Lead Integrity Algorithm download with a device download within the open and closed date of data collection
Key inclusion criteria (1 listed)
- Lead Integrity Algorithm download; requires a Medtronic device that supports the LIA algorithm; requires an RV lead; selected as part of the identified cohort
Key exclusion criteria (1 listed)
- A device that does not support the Lead Integrity Algorithm,
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
Sensitivity of the LIA algorithm
Time frame: 2 years
Positive predictive value of the LIA algorithm
Time frame: 2 years
Number of false positives per patient-year of the LIA algorithm
Time frame: 2 years
Reduction in the percent of patients with the LIA algorithm with an RV lead fracture who receive at least one inappropriate shock
Time frame: Event driven (analysis requires 50 events)
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 Mar 2018.
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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.
RVLIA Trial Leader study chair
Medtronic
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Medtronic.
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 1 inclusion and 1 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 Mar 2018. 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 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?
Sensitivity of the LIA algorithm (time frame: 2 years). The study lists 4 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 Mar 2018.