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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031989 on ClinicalTrials.gov