NCT02191696

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

July 14, 2014

Last Update Submit

January 28, 2015

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

IMED-4 recordingDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who present for CRM device follow-up are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.

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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Coast Cardiology

Encinitas, California, 92024, United States

Location

Desert Heart

Palm Springs, California, 92262, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 16, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

US(2)