Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation

Intersection Medical

Status: Completed

Conditions: Heart Failure

Treatments: Device: IMED-4 recording

Study type: Observational

Funder types: Industry

Identifiers

NCT02191696

CP-000050

Details and patient eligibility

About

The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)