Non-invasive Pulmonary Artery Prediction (ADOPTS)

Launched by SILVERLEAF MEDICAL SCIENCES INC · Nov 29, 2022

Keywords

ClinConnect Summary

A prototype device will be supplied by Silverleaf Medical Science (Redlands, CA) to record these signals. This study will take place at Loma Linda VA, in the cardiac catheterization lab as an add-on to clinically-indicated right heart catheterizations, and under the supervision of heart failure and interventional cardiologists. The investigators will screen and enroll 20 Veterans who consent to participate in the study. Veterans who decline to consent and vulnerable populations will be excluded from the study. The investigators will obtain simultaneous recordings from the prototype device (...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent and authorization to use and disclose health information.
• • 20 years of age or older.
• • Diagnosis of HF for \>3 months, with preserved or reduced left ventricular ejection fraction (LVEF).
• • Female subjects of childbearing age with a negative urine or serum pregnancy test at the time of the right heart cauterization procedure and trial.
• Exclusion Criteria:
• • Active infection.
• • Unable to tolerate a right heart catheterization (RHC), in the investigator's opinion.
• • Implantation of cardiac resynchronization therapy (CRT)\<3 months before enrollment.
• • Enrolled in concurrent studies that may confound the results of this study.
• • Clinical condition that would not allow them to complete the study, in the investigator's opinion.

Trial Officials