Status:
ACTIVE_NOT_RECRUITING
Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
Lead Sponsor:
Analytics For Life
Conditions:
Cardiovascular Diseases
Right Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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)...
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 mee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT04031989
Start Date
April 15 2019
End Date
August 31 2024
Last Update
March 4 2024
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
UC-MHS (UCHealth Memorial)
Colorado Springs, Colorado, United States, 80909
2
University of Colorado-MHS (UCHealth Memorial)
Colorado Springs, Colorado, United States, 80920
3
WellStar Research Institute
Marietta, Georgia, United States, 30060
4
Loyola University Chicago
Maywood, Illinois, United States, 60153