NCT04031989
Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
NA
ACTIVE_NOT_RECRUITING
NCT04031989
INTERVENTIONAL
Phase Signal Acquisition System (PSAQ): Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
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).
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.
Cardiovascular Diseases
Right Heart Failure
Cardiac Disease
- DIAGNOSTIC
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- Type: DEVICE
- Name: CorVista Capture
- Description: 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.
- Arm Group Labels: Enrolled Subjects (PSR)
- Analytics For Life