Repository of Phase Signals for Pulmonary Hypertension Algorithm Development (IDENTIFY - PH)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Cardiac Disease; Right Heart Failure
• Intervention / Treatment: Device: CorVista Capture

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.

• Study Type: Interventional
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • UC-MHS (UCHealth Memorial)
    • Colorado Springs, Colorado, United States, 80920
      • University of Colorado-MHS (UCHealth Memorial)
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar Research Institute
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Chicago
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates Research, LLC
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
  • New York
    • Rochester, New York, United States, 14621
      • The Rochester General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Greensboro, North Carolina, United States, 27401
      • LeBauer Cardiovascular Research Foundation
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional Medical Center
  • Pennsylvania
    • Natrona Heights, Pennsylvania, United States, 15065
      • Allegheny Health Network Research Institute
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network Research Institute
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Lexington, South Carolina, United States, 29169
      • Lexington Cardiology / Lexington Medical Heart and Vascular Center
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Hospitals and Sentara Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Analytics For Life
• Investigators: Study Director: Horace R Gillins, BS CCRP, CorVista Health; Study Director: William E Sanders, Jr, MD JD LLM MBA FHRS, CorVista Health

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pulmonary Hypertension; Right Heart Cath
• Additional Relevant MeSH Terms: Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Diseases; Hypertension; Cardiovascular Diseases; Hypertension, Pulmonary
• Other Study ID Numbers: PHDEV-CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes