The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output, Cardiac Power Output and Pulmonary Artery Pressure.in Patients Undergoing Right Heart Catheterization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing right heart catheterization for a clinical indication including but not limited to prognosis for advanced heart failure, during endomyocardial biopsy, candidacy for heart transplant or management of cardiogenic shock.
Study Design:
The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.
Number of subjects and sites:
The Nanowear SimpleSense study will enroll up to 100 subjects to collect data at Westchester Medical Center. The testing will include a SimpleSense device recording and simultaneous measurement of Cardiac Output, and Pulmonary Artery Pressure by right heart catheterization.
Duration of study:
The duration of the Nanowear SimpleSense study is expected to be 1 year.
Study Population:
Subjects of legal age to give informed consent who are undergoing right heart catheterization for a clinical indication including but not limited to :
- Prognosis of advanced heart failure
- During endomyocardial biopsy
- Candidacy for heart transplant
- Management of cardiogenic shock
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Valhalla, New York, United States, 10595
- Westchester Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Subjects of legal age to give informed consent who are
Undergoing right heart catheterization for a clinical indication including but not limited to :
- Prognosis of advanced heart failure
- During endomyocardial biopsy
- Candidacy for heart transplant
- Management of cardiogenic shock
Description
Inclusion Criteria:
- Subject has provided informed consent
- Male or female over the age of 18 years
- The patient is undergoing right heart catheterization
Exclusion Criteria:
- Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System.
- Subjects who are pregnant
- Severe aortic stenosis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Phase 1
Subjects to undergo right heart catheterization SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values. Undergoing right heart catheterization for a clinical indication including but not limited to :
|
The study is observational only.
No interventions will be triggered by the SimpleSense device
|
|
Phase 2
Subjects to undergo right heart catheterization SimpleSense data collected from the second set of subjects and evaluate the algorithms developed to estimate cardiac output from SimpleSense data.
The second set of subjects are from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.
|
The study is observational only.
No interventions will be triggered by the SimpleSense device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac output algorithm
Time Frame: 9-12 months
|
To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization.
|
9-12 months
|
|
Algorithm for Pulmonary Artery Pressure
Time Frame: 9 -12 months
|
To train a model for Pulmonary Artery Pressure estimation based on the data acquired for SimpleSense against the Pulmonary Artery Pressure data from the right heart catheterization
|
9 -12 months
|
|
Algorithm for Pulmonary Wedge Pressure
Time Frame: 9-12 months
|
To train a model for Pulmonary Wedge Pressure estimation based on the data acquired for SimpleSense against the Pulmonary Wedge Pressure data from the right heart catheterization
|
9-12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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