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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191696
• Other study ID #: CP-000050
• Status: Completed
• Phase: N/A
• First received: July 14, 2014
• Last updated: January 28, 2015
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Intersection Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• IMED-4 recording

Locations

Country	Name	City	State
United States	North Coast Cardiology	Encinitas	California
United States	Desert Heart	Palm Springs	California

Sponsors (1)

Lead Sponsor	Collaborator
Intersection Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IMED-4 recordings	The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects.	6 months	Yes