- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361333
Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators
January 12, 2018 updated by: Yale University
The purpose of this study is to determine whether a teaching intervention can help increase the use of remote monitors in patients with implantable cardioverter defibrillators.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Yale Electrophysiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Received a Medtronic implantable cardioverter defibrillator (ICD) at Yale Electrophysiology, between January 2007 and June 2012
- ICD is compatible with Carelink, Medtronic's remote monitoring system
Exclusion Criteria:
- Less than 18 years of age
- From a vulnerable population
- Incompetent/suffers from dementia
- Non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Teaching Intervention
Patients will be taught how to install and use a remote monitor.
|
Patients will be taught how to install and use a remote monitor
|
No Intervention: No Intervention
Patients will not be taught how to install and use a remote monitor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of remote Transmissions of data using remote monitor made by patient
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
January 20, 2015
First Submitted That Met QC Criteria
February 10, 2015
First Posted (Estimate)
February 11, 2015
Study Record Updates
Last Update Posted (Actual)
January 17, 2018
Last Update Submitted That Met QC Criteria
January 12, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 1208010730
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Implantable Cardioverter Defibrillator
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Paris Cardiovascular Research Center (Inserm U970)Hôpital Necker-Enfants MaladesCompletedImplantable Defibrillator User | Implantable Cardioverter Defibrillator Complications
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Biotronik, Inc.CompletedImplantable Cardioverter-Defibrillator With Magnetic Resonance ImagingUnited States
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Biotronik (Beijing) Medical Device Ltd.CompletedNeed for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
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