Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
NCT04031989 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500
Last updated 2024-03-04
Summary
This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to Right Heart Cath (RHC). The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by CorVista Health (formerly Analytics 4 Life).
Conditions
- Cardiovascular Diseases
- Right Heart Failure
- Cardiac Disease
Interventions
- DEVICE
-
CorVista Capture
The CorVista System is a medical device system that is being developed to collect phase signals from patients to support the development and testing of machine learned algorithms developed by CorVista Health. Data collected with the CorVista System during this study will not be used to guide treatment.
Sponsors & Collaborators
-
Analytics For Life
lead INDUSTRY
Principal Investigators
-
Horace R Gillins, BS CCRP · CorVista Health
-
William E Sanders, Jr, MD JD LLM MBA FHRS · CorVista Health
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-15
- Primary Completion
- 2024-05-15
- Completion
- 2024-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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