Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
Status unconfirmed · Not applicable
Conditions studied: Cardiovascular Diseases, Right Heart Failure, Cardiac Disease
In brief
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).
Key facts
- Study ID
- NCT04031989
- Run by
- Analytics For Life
- People needed
- 2500
- Starts
- 2019-04-15
- Expected to finish
- 2024-08-31
- Last updated by the study team
- 2024-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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