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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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IMED-4 recording

Intervention Type DEVICE

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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North Coast Cardiology

Encinitas, California, United States

Site Status

Desert Heart

Palm Springs, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-000050

Identifier Type: -

Identifier Source: org_study_id