Bioimpedance Spectroscopy Compared to CardioMEMS™
July 5, 2019 updated by: ImpediMed Limited
Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure.
The study will recruit and enroll ten participants from the Scripps Clinic.
Participants will be monitored 3 times a week for a period of 4 weeks.
At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology.
Participant's vital signs and weight will also be taken at each monitoring visit.
Study Type
Observational
Enrollment (Actual)
16
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
-
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California
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La Jolla, California, United States, 92037
- Scripps Clinic, John R. Anderson V Medical Pavilion
-
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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
Sampling Method
Non-Probability Sample
Study Population
Heart failure patients who have a CardioMEMS device
Description
Inclusion Criteria:
Patient:
- has an CardioMEMs device implanted
- has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
- is able to give informed consent
Exclusion Criteria:
Patient:
- has pacemaker/ICD
- is pregnant or breastfeeding
- is an amputee
- has been diagnosed with multiple medical conditions that would make participation burdensome
- not able to co-operate with impedance measurements
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in bioimpedance measurement at 4 weeks
Time Frame: Baseline and 4 weeks
|
Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures
|
Baseline and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
August 7, 2017
Primary Completion (Actual)
March 19, 2018
Study Completion (Actual)
October 9, 2018
Study Registration Dates
First Submitted
July 27, 2016
First Submitted That Met QC Criteria
August 2, 2016
First Posted (Estimate)
August 5, 2016
Study Record Updates
Last Update Posted (Actual)
July 8, 2019
Last Update Submitted That Met QC Criteria
July 5, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPD-SCRIPPS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a pilot study, no individual participant data will be made available.
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.