Status:
COMPLETED
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
Lead Sponsor:
Intersection Medical, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02191696
Start Date
June 1 2014
End Date
January 1 2015
Last Update
January 30 2015
Active Locations (2)
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1
North Coast Cardiology
Encinitas, California, United States, 92024
2
Desert Heart
Palm Springs, California, United States, 92262