NCT00870324CompletedNot Applicable
OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration).
Study Overview
Brief Summary
The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The performance of the lead will be measured as a difference in device-determined time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to the control group which will be randomized to receive SJM's Tendril™ RA leads.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who meets current ICD or CRT-D implant indications and receive a St. Jude Medical ICD/CRT-D
- •Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant
Exclusion Criteria
- •Patients with a history of Permanent or Persistent AF
- •Patient's life expectancy is less than 12 months.
- •Patient is pregnant.
- •Patient's age at enrollment is less than 18 years.
Outcomes
Primary Outcomes
The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration).
Time Frame: 3 months post-implant
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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