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Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

NCT03243942 PHASE2 COMPLETED

The fundamental hypothesis of this project is that real-time intracardiac pressures can be monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast echocardiography to assess the accuracy of SHAPE compared to simultaneously acquired intracardiac 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.

Details

Lead sponsorThomas Jefferson University
PhasePHASE2
StatusCOMPLETED
Enrolment56
Start dateThu Jun 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionWed Jun 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States