Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
- Conditions
- Cardiovascular DiseasesRight Heart FailureCardiac Disease
- Interventions
- Device: CorVista Capture
- Registration Number
- NCT04031989
- Lead Sponsor
- Analytics For Life
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enrolled Subjects (PSR) CorVista Capture 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.
- Primary Outcome Measures
Name Time Method Phase Signal Recorder Procedure 7 day Resting phase signals will be collected from eligible subjects prior to Right Heart Catheterization.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
University of Colorado-MHS (UCHealth Memorial)
🇺🇸Colorado Springs, Colorado, United States
UC-MHS (UCHealth Memorial)
🇺🇸Colorado Springs, Colorado, United States
WellStar Research Institute
🇺🇸Marietta, Georgia, United States
Loyola University Chicago
🇺🇸Maywood, Illinois, United States
Bryan Heart
🇺🇸Lincoln, Nebraska, United States
The Rochester General Hospital
🇺🇸Rochester, New York, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Allegheny Health Network Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Sentara Hospitals and Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
Austin Heart
🇺🇸Austin, Texas, United States
Cardiology Associates Research, LLC
🇺🇸Tupelo, Mississippi, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Lexington Cardiology / Lexington Medical Heart and Vascular Center
🇺🇸Lexington, South Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States