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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Canada, 

Outcome

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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