Clinical trial NCT05629533: The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
Official title: The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output, Cardiac Power Output and Pulmonary Artery Pressure.in Patients Undergoing Right Heart Catheterization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Heart Catheterization
Keywords: Cardiac output
Right heart catheterization
SimpleSense
Algorithm
Pulmonary Artery Pressure
Heart failure
Endomyocardial biopsy
Cardiogenic shock
Lead sponsor: Nanowear Inc.
Sponsor class: INDUSTRY
Collaborators: name: Westchester Medical Center
First posted: 2022-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiac output algorithm
timeFrame: 9-12 months
measure: Algorithm for Pulmonary Artery Pressure
timeFrame: 9 -12 months
measure: Algorithm for Pulmonary Wedge Pressure
timeFrame: 9-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
Study officials:
References: