The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

Description

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.

Conditions

Right Heart Catheterization

Study Overview

Study Details

Study overview

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.

The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output, Cardiac Power Output and Pulmonary Artery Pressure.in Patients Undergoing Right Heart Catheterization

The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

Condition
Right Heart Catheterization
Intervention / Treatment

-

Contacts and Locations

Valhalla

Westchester Medical Center, Valhalla, New York, United States, 10595

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System.
  • 2. Subjects who are pregnant
  • 3. Severe aortic stenosis.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nanowear Inc.,

Study Record Dates

2024-12-01