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

Completed

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT02191696

Run by

Intersection Medical, Inc.

People needed

24

Starts

2014-06-01

Expected to finish

2015-01-01

Last updated by the study team

2015-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• North Coast Cardiology — Encinitas, California, United States
• Desert Heart — Palm Springs, California, United States

Full record on ClinicalTrials.gov

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