Clinical trial NCT00832988: CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements
Official title: Comparison of in Office Interrogation vs. Remote Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker
Keywords: pacing thresholds
sensing
impedance
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary device clinic

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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
timeFrame: 12 and 18 months post-implant
Secondary outcomes:
measure: 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.
timeFrame: 12 and 18 months post-implant
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: North Shore Heart Group
state: British Columbia
city: Brampton
country: Canada
facility: William Osler Health Centre
state: Ontario
city: Peterborough
country: Canada
facility: Peterborough Regional
state: Ontario
city: Québec
country: Canada
facility: Clinique de Cardiologie Desilets
state: Quebec
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec
state: Quebec
Study officials:
References: