Repository of Phase Signals for Pulmonary Hypertension Algorithm Development (IDENTIFY - PH)

Analytics For Life

Status: Active, not recruiting

Conditions: Cardiac Disease; Right Heart Failure; Cardiovascular Diseases

Treatments: Device: CorVista Capture

Study type: Interventional

Funder types: Industry

Identifiers

NCT04031989

PHDEV-CIP-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,500 participants in 1 patient group

Enrolled Subjects (PSR)

Other group

Description:

Patients who meet the study's entrance criteria and provide written informed consent, will undergo signal acquisition prior to their scheduled right heart catheterization (RHC) on the day of the procedure.

Treatment:

Device: CorVista Capture