NCT04031989

Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

Phase Signal Acquisition System (PSAQ): Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: Analytics For Life · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Male and Female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals. Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and right heart catheterization. In this study, resting phase signals will be acquired in subjects prior to Right Heart Catheterization.

Conditions

• Cardiovascular Diseases
• Right Heart Failure
• Cardiac Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-15
• Primary completion: 2024-05-15
• Completion: 2024-08-31
• First posted: 2019-07-25
• Last updated: 2024-03-04

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study