Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04031989
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Analytics For Life
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Horace R Gillins, BS CCRPWilliam E Sanders, Jr, MD JD LLM MBA FHRS
Principal Investigator Affiliation CorVista HealthCorVista Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cardiovascular Diseases, Right Heart Failure, Cardiac Disease
Additional Details

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.

Arms & Interventions

Arms

Other: Enrolled Subjects (PSR)

Patients who meet the study's entrance criteria and provide written informed consent, will undergo signal acquisition prior to their scheduled right heart catheterization (RHC) on the day of the procedure.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC-MHS (UCHealth Memorial), Colorado Springs, Colorado

Status

Address

UC-MHS (UCHealth Memorial)

Colorado Springs, Colorado, 80909

Colorado Springs, Colorado

Status

Address

University of Colorado-MHS (UCHealth Memorial)

Colorado Springs, Colorado, 80920

WellStar Research Institute, Marietta, Georgia

Status

Address

WellStar Research Institute

Marietta, Georgia, 30060

Loyola University Chicago, Maywood, Illinois

Status

Address

Loyola University Chicago

Maywood, Illinois, 60153

Cardiology Associates Research, LLC, Tupelo, Mississippi

Status

Address

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801

Bryan Heart, Lincoln, Nebraska

Status

Address

Bryan Heart

Lincoln, Nebraska, 68506

The Rochester General Hospital, Rochester, New York

Status

Address

The Rochester General Hospital

Rochester, New York, 14621

Duke University, Durham, North Carolina

Status

Address

Duke University

Durham, North Carolina, 27710

Greensboro, North Carolina

Status

Address

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401

New Hanover Regional Medical Center, Wilmington, North Carolina

Status

Address

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401

Natrona Heights, Pennsylvania

Status

Address

Allegheny Health Network Research Institute

Natrona Heights, Pennsylvania, 15065

Pittsburgh, Pennsylvania

Status

Address

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212

AnMed Health, Anderson, South Carolina

Status

Address

AnMed Health

Anderson, South Carolina, 29621

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Lexington, South Carolina

Status

Address

Lexington Cardiology / Lexington Medical Heart and Vascular Center

Lexington, South Carolina, 29169

Austin Heart, Austin, Texas

Status

Address

Austin Heart

Austin, Texas, 78756

Norfolk, Virginia

Status

Address

Sentara Hospitals and Sentara Medical Group

Norfolk, Virginia, 23507

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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