Right Heart Catheterization
Conditions
Keywords
Cardiac output, Right heart catheterization, SimpleSense, Algorithm, Pulmonary Artery Pressure, Heart failure, Endomyocardial biopsy, Cardiogenic shock
Brief summary
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.
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
Interventions
DEVICESimpleSense
The study is observational only. No interventions will be triggered by the SimpleSense device
Sponsors
Nanowear Inc.
Westchester Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has provided informed consent 2. Male or female over the age of 18 years 3. The patient is undergoing right heart catheterization
Exclusion criteria
1. Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System. 2. Subjects who are pregnant 3. Severe aortic stenosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac output algorithm | 9-12 months | To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization. |
| Algorithm for Pulmonary Artery Pressure | 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 |
| Algorithm for Pulmonary Wedge Pressure | 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 |
Countries
United States
Outcome results
None listed