Heart Failure
Conditions
Brief 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.
Interventions
DEVICEIMED-4 recording
Sponsors
Intersection Medical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with an active implantable CRM device * Subjects \> 18 years of age * Subjects who are ambulatory not requiring assistance for ambulation * Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB
Exclusion criteria
* Subjects who are pregnant or lactating or who have been pregnant within the past three months * Subjects who have tattoos on the back in the electrode patch placement region * Subjects who have had a past allergic reaction to adhesives * Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IMED-4 recordings | 6 months | The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects. |
Countries
United States
Outcome results
None listed