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UNKNOWNNANCT04031989

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)...

Lead sponsor: Analytics For Life•17 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Analytics For Life

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 4, 2024Terms

Trial snapshot

StatusUNKNOWN

PhaseNA

Enrollment2,500

Start dateApr 2019

Last updatedMar 4, 2024

Condition

Cardiovascular Diseases Right Heart Failure Cardiac Disease

Locations shown

UC-MHS (UCHealth Memorial)

Colorado Springs, Colorado

University of Colorado-MHS (UCHealth Memorial)

Colorado Springs, Colorado

WellStar Research Institute

Marietta, Georgia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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