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

Completed

• Conditions: Heart Failure

• Registration Number: NCT02191696
• Lead Sponsor: Intersection Medical, Inc.

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-16
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

North Coast Cardiology; 🇺🇸 Encinitas, California, United States

Desert Heart; 🇺🇸 Palm Springs, California, United States