Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

NCT04031989 | Active Not Recruiting FDA Device

• 1 other identifier: PHDEV-CIP-001
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 17

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).

Conditions

Cardiovascular Diseases; Right Heart Failure; Cardiac Disease

Keywords

Pulmonary Hypertension; Right Heart Cath

Outcome Measures

Primary Outcomes (1)

• Phase Signal Recorder Procedure

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

  7 day

Study Arms (1)

Enrolled Subjects (PSR)

OTHER

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.

Device: CorVista Capture

Interventions

CorVista Capture DEVICE

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.

Enrolled Subjects (PSR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Analytics For Life: lead

Study Sites (17)

UC-MHS (UCHealth Memorial)

Colorado Springs, Colorado, 80909, United States

Location

University of Colorado-MHS (UCHealth Memorial)

Colorado Springs, Colorado, 80920, United States

Location

WellStar Research Institute

Marietta, Georgia, 30060, United States

Location

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

The Rochester General Hospital

Rochester, New York, 14621, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Allegheny Health Network Research Institute

Natrona Heights, Pennsylvania, 15065, United States

Location

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

AnMed Health

Anderson, South Carolina, 29621, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Lexington Cardiology / Lexington Medical Heart and Vascular Center

Lexington, South Carolina, 29169, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Sentara Hospitals and Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure; Heart Diseases; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Horace R Gillins, BS CCRP

  CorVista Health

  STUDY DIRECTOR

• William E Sanders, Jr, MD JD LLM MBA FHRS

  CorVista Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: April 15, 2019
• Primary Completion: May 15, 2024
• Study Completion: August 31, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)