Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Diseases; Right Heart Failure; Cardiac Disease

• Registration Number: NCT04031989
• Lead Sponsor: Analytics For Life

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). 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).

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 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.

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2024-05-15
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Phase Signal Recorder Procedure	7 day	Resting phase signals will be collected from eligible subjects prior to Right Heart Catheterization.

Trial Locations

Locations (16)

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

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