drugset / Trial / NCT03245255

Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound

NCT03245255

NaSingle-groupOpen-labelDiagnostic

Summary

This study will use contrast echocardiography to assess the accuracy of a new non-invasive imaging method for subharmonic aided pressure estimation (SHAPE) compared to simultaneously acquired intra-cardiac pressures measured invasively during cardiac catheterization. This study is designed to verify that contrast echocardiography using the SHAPE method, already proven in a canine model and tested in a human pilot study can be used as a surrogate for cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.

Timeline

Start
2017-12-04
Primary completion
2020-09-18
Completion
2023-06-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Perflubutane Diagnostic / imaging agent 0.048 ml Other

Indications