Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
NCT ID: NCT04031989
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2500 participants
INTERVENTIONAL
2019-04-15
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Analytics For Life
INDUSTRY
Responsible Party
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Principal Investigators
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Horace R Gillins, BS CCRP
Role: STUDY_DIRECTOR
CorVista Health
William E Sanders, Jr, MD JD LLM MBA FHRS
Role: STUDY_DIRECTOR
CorVista Health
Locations
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UC-MHS (UCHealth Memorial)
Colorado Springs, Colorado, United States
University of Colorado-MHS (UCHealth Memorial)
Colorado Springs, Colorado, United States
WellStar Research Institute
Marietta, Georgia, United States
Loyola University Chicago
Maywood, Illinois, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Bryan Heart
Lincoln, Nebraska, United States
The Rochester General Hospital
Rochester, New York, United States
Duke University
Durham, North Carolina, 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
Natrona Heights, Pennsylvania, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
AnMed Health
Anderson, South Carolina, 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
Austin Heart
Austin, Texas, United States
Sentara Hospitals and Sentara Medical Group
Norfolk, Virginia, United States
Countries
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Other Identifiers
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PHDEV-CIP-001
Identifier Type: -
Identifier Source: org_study_id
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