cPSTA System CADLAD Study

Analytics For Life

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Phase Signal Recorder

Study type: Interventional

Funder types: Industry

Identifiers

NCT02784197

BSA-CD-001

Details and patient eligibility

About

This study is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient.

Full description

This clinical protocol is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient. In addition to this primary objective, machine-learned algorithms will be developed and tested to report the left ventricular ejection fraction and to identify the location of significant coronary artery disease. The performance of the machine-learned algorithm will be evaluated using a comparative paired trial design. In this study, the physician will not be provided the results of analysis performed and, accordingly, the results of the analyses will not be used to guide treatment decisions for the patient.

Enrollment: 2,622 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥21 years of age at the time of screening
2. Meets criteria for coronary angiography
3. Scheduled to undergo cardiac catheterization with coronary angiography
4. Ability to understand the requirements of the study and to provide written informed consent

Exclusion criteria

1. Prior documented myocardial infarction (MI)
2. Prior coronary artery bypass grafting (CABG) or previous coronary interventions (PCI)
3. Indication for invasive coronary angiography other than to assess for obstructive CAD (e.g., arrhythmia, cardiomyopathy, valvular abnormality)
4. Previous heart valve replacement
5. Previous sustained or paroxysmal atrial or ventricular arrhythmia
6. Infiltrative myocardial disease (Amyloid, Sarcoid, Right ventricular dysplasia)
7. Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors
8. Implantable Neuro-stimulators
9. Congenital Heart Disease
10. Pregnancy (breast feeding)
11. Currently taking any Type IA, IC or III antiarrhythmic
12. Any history of Amiodarone therapy
13. Clinically significant chest deformity (e.g., pectus excavatum or pectus carnitatum)
14. Breast implants
15. 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)

---

2,622 participants in 1 patient group

Enrolled Subjects (PSR)

Other group

Description:

Patients who meet the study's inclusion and exclusion criteria, including signing the informed consent form, subjects will undergo signal acquisition prior to their scheduled cardiac catheterization on the day of the procedure.

Treatment:

Device: Phase Signal Recorder