Right Heart CatheterizationNCT05629533
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
An observational study of Right Heart Catheterization, run by Nanowear Inc. at 1 site in United States.
Trial 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.'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Heart Catheterization
- What is being tested?
- SimpleSense
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Subject has provided informed consent
- Male or female over the age of 18 years
- The patient is undergoing right heart catheterization
Who cannot join
- Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System.
- Subjects who are pregnant
- Severe aortic stenosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Westchester Medical Center
Valhalla, New York, 10595
About this study
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
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.
Read the 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
- Conditions
- Right Heart Catheterization
- Being tested
- SimpleSense
- Keywords
- Cardiac output, Right heart catheterization, SimpleSense, Algorithm, Pulmonary Artery Pressure, Heart failure, Endomyocardial biopsy, Cardiogenic shock
- Medical subject headings
- Heart Failure, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimpleSenseDevice
The study is observational only. No interventions will be triggered by the SimpleSense device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: SimpleSense | |
| 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. Receives: Device: SimpleSense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output algorithm
To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization.
Measured: 9-12 months
Algorithm for Pulmonary Artery Pressure
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
Measured: 9 -12 months
Algorithm for Pulmonary Wedge Pressure
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
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start8 Mar 2023
- Primary completion5 Mar 2025
- Study completion31 May 2025
Why it stopped: Logistics and low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Heart CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanowear Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Westchester Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629533
- Sponsor's protocol ID
- 14-0044
- Status last verified
- Apr 2026
- First submitted
- 10 Nov 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05629533
- Acronym / sponsor ID
- 14-0044
- Conditions
- Right Heart Catheterization
- Keywords
- Cardiac output, Right heart catheterization, SimpleSense, Algorithm, Pulmonary Artery Pressure, Heart failure, Endomyocardial biopsy, Cardiogenic shock
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Logistics and low enrollment.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nanowear Inc.Industry (pharma, biotech, devices)
- Collaborators
- Westchester Medical Center
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Device: SimpleSenseSubjects 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 |
| Phase 2 | – | Device: SimpleSenseSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Subject has provided informed consent
- Male or female over the age of 18 years
- The patient is undergoing right heart catheterization
Key exclusion criteria (3 listed)
- Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System.
- Subjects who are pregnant
- Severe aortic stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimpleSenseThe study is observational only. No interventions will be triggered by the SimpleSense device | Device | Phase 1, Phase 2 |
Primary outcome
Cardiac output algorithm
Time frame: 9-12 months
To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization.
Algorithm for Pulmonary Artery Pressure
Time frame: 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
Time frame: 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
Results and safety
The study was stopped early (reason given: Logistics and low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Heart Catheterization, run by Nanowear Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Logistics and low enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output algorithm (time frame: 9-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 4 Nov 2026.