Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04031989

Acronym

IDENTIFY - PH

Enrollment

2500

Registered

2019-07-25

Start date

2019-04-15

Completion date

2024-08-31

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Cardiovascular Diseases, Right Heart Failure

Keywords

Pulmonary Hypertension, Right Heart Cath

Brief 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.

Interventions

DEVICECorVista 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Repository study designed to collect signals using the CorVista Capture in subjects scheduled for Right Heart Catheterization

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients ≥ 18 years old; 2. Scheduled to undergo right heart catheterization; 3. Ability to understand the requirements of the study and to provide written informed consent. 4. Normal Sinus Rhythm (SSR) at time of phase signal collection.

Exclusion criteria

1. Prior heart valve replacement 2. Prior lung or heart transplant 3. Infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia); 4. Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors; 5. Implantable Neuro-stimulators; 6. Congenital Heart Disease; 7. Pregnant or breast feeding; 8. Currently taking any Type IA, IC or III antiarrhythmics; 9. Any history of amiodarone use; 10. Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum); 11. Breast implants; 12. Neuromuscular Disease if the condition results in tremor or muscle fasciculations.

Design outcomes

Primary

Measure	Time frame	Description
Phase Signal Recorder Procedure	7 day	Resting phase signals will be collected from eligible subjects prior to Right Heart Catheterization.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026