Validation of a wearable system for measuring 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
Nanowear Inc. · NCT05629533
This study is testing a new wearable device to see if it can accurately measure heart output in patients who are having a specific heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanowear Inc. (industry) |
| Locations | 1 site (Valhalla, New York) |
| Trial ID | NCT05629533 on ClinicalTrials.gov |
What this trial studies
The Nanowear SimpleSense study is an observational trial designed to validate the SimpleSense wearable system for estimating cardiac output in patients undergoing right heart catheterization. It consists of two phases: the first phase will correlate data from the SimpleSense device with values obtained from right heart catheterization, while the second phase will evaluate algorithms developed to estimate cardiac output using data from a separate group of subjects. The study aims to enroll up to 100 participants at Westchester Medical Center over the course of one year.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for right heart catheterization due to conditions like advanced heart failure or candidacy for heart transplant.
Not a fit: Patients who are pregnant or have severe aortic stenosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for monitoring cardiac output, improving patient management in heart-related conditions.
How similar studies have performed: Other studies have explored wearable technology for cardiac monitoring, but this specific approach using the SimpleSense system is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Valhalla, New York
- Westchester Medical Center — Valhalla, New York, United States (RECRUITING)
Study contacts
- Study coordinator: Venk Varadan
- Email: venk@nanowearinc.com
- Phone: (718) 637-4815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Right Heart Catheterization, Cardiac output, Right heart catheterization, SimpleSense, Algorithm, Pulmonary Artery Pressure, Heart failure, Endomyocardial biopsy