Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

N/AUnknownNCT04031989

Analytics For Life2,500 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,500

Conditions

Cardiovascular Diseases Right Heart Failure Cardiac Disease

Interventions

CorVista CaptureDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

UC-MHS (UCHealth Memorial)

Colorado Springs, Colorado, United States

University of Colorado-MHS (UCHealth Memorial)

Colorado Springs, Colorado, United States

Outcomes

Primary Outcomes

Phase Signal Recorder Procedure

Resting phase signals will be collected from eligible subjects prior to Right Heart Catheterization.

Time frame: 7 day

Data from ClinicalTrials.gov

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