PacemakerCONFIRMNCT00832988
CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
An observational study of Pacemaker, run by Abbott Medical Devices at 6 sites in Canada.
Trial summary
The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker
- What is being tested?
- VentricularAutoCaptureTM & ACapTM Confirm
- How many people
- 115 participants
- Where
- 6 sitesCanada
- Study dates
- Oct 2008to Feb 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary device clinic
Who may be able to join
- Patients have been implanted with their device ~ 6 months prior
- Patients must have their device evaluated at the enrolling center.
- Patients must be able to comply with the regular routine follow-up schedule of the enrolling clinic.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
- Patients age 18 or greater.
Who cannot join
- Patient has a unipolar atrial lead implanted.
- Patients who are or may potentially be pregnant.
- Patients with persistent AF.
- Less than 1 year life expectancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
William Osler Health Centre
Brampton, Ontario, L6R 3J7
Kelowna General Hospital
Kelowna, British Columbia
Peterborough Regional
Peterborough, Ontario
Clinique de Cardiologie Desilets
Québec, Quebec, G1J 1Z6
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1R 2J6
North Shore Heart Group
Vancouver, British Columbia, V7L2P7
About this study
Official title: Comparison of in Office Interrogation vs. Remote Measurements
The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient; to compare the accuracy of the automated device test results to manual testing results; evaluate the percentage of patients who are recommended for ACapTM Confirm utilization.
The Primary Hypotheses are:
- The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic.
- The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.
- Conditions
- Pacemaker
- Being tested
- VentricularAutoCaptureTM & ACapTM Confirm
- Keywords
- pacing thresholds, sensing, impedance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentricularAutoCaptureTM & ACapTM ConfirmOther
Also called Zephyr™ pacemaker, VentricularAutoCaptureTM, ACapTM Confirm
The testing algorithms allow the device to display threshold measurements at time of device interrogation. These will be evaluated against manual testing results.
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker patients | Patients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible Receives: Other: VentricularAutoCaptureTM & ACapTM Confirm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
Measured: 12 and 18 months post-implant
Secondary outcomes (1)
To compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient.
Measured: 12 and 18 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832988
- Sponsor's protocol ID
- SJM LV001
- Acronym
- CONFIRM
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of in Office Interrogation vs. Remote Measurements
- ClinicalTrials.gov ID
- NCT00832988
- Acronym / sponsor ID
- CONFIRM / SJM LV001
- Conditions
- Pacemaker
- Keywords
- pacing thresholds, sensing, impedance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 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 primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient; to compare the accuracy of the automated device test results to manual testing results; evaluate the percentage of patients who are recommended for ACapTM Confirm utilization.
The Primary Hypotheses are:
- The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic.
- The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker patients | – | Other: VentricularAutoCaptureTM & ACapTM ConfirmPatients who are implanted with a SJM Zephyr™ DR device for a standard pacing indication will be eligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary device clinic
Key inclusion criteria (5 listed)
- Patients have been implanted with their device ~ 6 months prior
- Patients must have their device evaluated at the enrolling center.
- Patients must be able to comply with the regular routine follow-up schedule of the enrolling clinic.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
- Patients age 18 or greater.
Key exclusion criteria (4 listed)
- Patient has a unipolar atrial lead implanted.
- Patients who are or may potentially be pregnant.
- Patients with persistent AF.
- Less than 1 year life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VentricularAutoCaptureTM & ACapTM ConfirmAlso: Zephyr™ pacemaker, VentricularAutoCaptureTM, ACapTM ConfirmThe testing algorithms allow the device to display threshold measurements at time of device interrogation. These will be evaluated against manual testing results. | Other | Pacemaker patients |
Primary outcome
Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
Time frame: 12 and 18 months post-implant
1 secondary outcome
To compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient.
Time frame: 12 and 18 months post-implant
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 4 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker, run by Abbott Medical Devices at 6 sites in Canada.
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 5 inclusion and 4 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds (time frame: 12 and 18 months post-implant). 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 4 Feb 2019.