Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-01 @ 2:12 AM
Study NCT ID:
NCT05629533
Status:
UNKNOWN
Last Update Posted:
2023-11-09
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
Sponsor:
Nanowear Inc.
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: