The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
NCT ID: NCT05629533
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
100 participants
OBSERVATIONAL
2023-03-08
2024-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nanowear Heart Failure Management Multi-sensor Algorithm
NCT03719079
Smart Textile Sensor System for Health Monitoring
NCT05473702
Non-invasive Pulmonary Artery Prediction
NCT05622695
Assess Measurements of Wireless Cardiac Output Device
NCT02252757
Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output
NCT04255108
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 :
* Prognosis of advanced heart failure
* During endomyocardial biopsy
* Candidacy for heart transplant
* Management of cardiogenic shock
SimpleSense
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.
SimpleSense
The study is observational only. No interventions will be triggered by the SimpleSense device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SimpleSense
The study is observational only. No interventions will be triggered by the SimpleSense device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or female over the age of 18 years
3. The patient is undergoing right heart catheterization
Exclusion Criteria
2. Subjects who are pregnant
3. Severe aortic stenosis.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Westchester Medical Center
OTHER
Nanowear Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Westchester Medical Center
Valhalla, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14-0044
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.