Pacemaker Clinical Trial
— CONFIRMOfficial title:
Comparison of in Office Interrogation vs. Remote Measurements
NCT number | NCT00832988 |
Other study ID # | SJM LV001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2008 |
Est. completion date | February 2013 |
Verified date | February 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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:
1. The values reported from ACapTM Confirm will be within 0.125 V of the value that is
obtained manually in clinic.
2. The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value
that is obtained manually in clinic.
Status | Completed |
Enrollment | 115 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | William Osler Health Centre | Brampton | Ontario |
Canada | Kelowna General Hospital | Kelowna | British Columbia |
Canada | Peterborough Regional | Peterborough | Ontario |
Canada | Centre Hospitalier Universitaire de Québec | Québec | Quebec |
Canada | Clinique de Cardiologie Desilets | Québec | Quebec |
Canada | North Shore Heart Group | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds | 12 and 18 months post-implant | ||
Secondary | 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. | 12 and 18 months post-implant |
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