Status:
COMPLETED
CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
Lead Sponsor:
Abbott Medical Devices
Conditions:
Pacemaker
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00832988
Start Date
October 1 2008
End Date
February 1 2013
Last Update
February 4 2019
Active Locations (6)
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1
Kelowna General Hospital
Kelowna, British Columbia, Canada
2
North Shore Heart Group
Vancouver, British Columbia, Canada, V7L2P7
3
William Osler Health Centre
Brampton, Ontario, Canada, L6R 3J7
4
Peterborough Regional
Peterborough, Ontario, Canada