Clinical trial NCT04031989: Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
Official title: Phase Signal Acquisition System (PSAQ): Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Right Heart Failure
Cardiac Disease
Keywords: Pulmonary Hypertension
Right Heart Cath
Lead sponsor: Analytics For Life
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repository study designed to collect signals using the CorVista Capture in subjects scheduled for Right Heart Catheterization
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility 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.

Primary outcomes:
measure: Phase Signal Recorder Procedure
timeFrame: 7 day
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: UC-MHS (UCHealth Memorial)
state: Colorado
city: Colorado Springs
country: United States
facility: University of Colorado-MHS (UCHealth Memorial)
state: Colorado
city: Marietta
country: United States
facility: WellStar Research Institute
state: Georgia
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Rochester
country: United States
facility: The Rochester General Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Natrona Heights
country: United States
facility: Allegheny Health Network Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network Research Institute
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Lexington
country: United States
facility: Lexington Cardiology / Lexington Medical Heart and Vascular Center
state: South Carolina
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Norfolk
country: United States
facility: Sentara Hospitals and Sentara Medical Group
state: Virginia
Study officials:
affiliation: CorVista Health
name: Horace R Gillins, BS CCRP
role: STUDY_DIRECTOR
affiliation: CorVista Health
name: William E Sanders, Jr, MD JD LLM MBA FHRS
role: STUDY_DIRECTOR
References: