Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

Cardiovascular Diseases Clinical Trial

— IDENTIFY - PH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04031989
• Other study ID #: PHDEV-CIP-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Analytics For Life
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: August 31, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiovascular Diseases
• Heart Diseases
• Hypertension
• Hypertension, Pulmonary
• Right Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	AnMed Health	Anderson	South Carolina
United States	Austin Heart	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	UC-MHS (UCHealth Memorial)	Colorado Springs	Colorado
United States	University of Colorado-MHS (UCHealth Memorial)	Colorado Springs	Colorado
United States	Duke University	Durham	North Carolina
United States	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	Lexington Cardiology / Lexington Medical Heart and Vascular Center	Lexington	South Carolina
United States	Bryan Heart	Lincoln	Nebraska
United States	WellStar Research Institute	Marietta	Georgia
United States	Loyola University Chicago	Maywood	Illinois
United States	Allegheny Health Network Research Institute	Natrona Heights	Pennsylvania
United States	Sentara Hospitals and Sentara Medical Group	Norfolk	Virginia
United States	Allegheny Health Network Research Institute	Pittsburgh	Pennsylvania
United States	The Rochester General Hospital	Rochester	New York
United States	Cardiology Associates Research, LLC	Tupelo	Mississippi
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Analytics For Life

Country where clinical trial is conducted

United States, 

Outcome

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