Trials / Completed
CompletedNCT02191696
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (actual)
- Sponsor
- Intersection Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
Detailed description
The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device programmer will print the voltage sensing of the implanted lead in real-time. The printout will be examined for the presence of far-field sensing artifacts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IMED-4 recording |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2014-07-16
- Last updated
- 2015-01-30
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02191696. Inclusion in this directory is not an endorsement.