NCT03245255

Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Catheterization
• Blood Pressure
• Heart Ventricles
• Echocardiography
• Heart Failure

Interventions

Type	Name	Description
DRUG	Sonazoid	Whenever a patient undergoes cardiac catheterization, which routinely includes intracardiac pressure monitoring using a pressure catheter, as part of their standard clinical care and agrees to participate in the study, we will acquire research data. With Sonazoid infusion, SHAPE algorithm will be initiated to determine optimum acoustic pressure. Then, at the optimum acoustic pressure, SHAPE specific data will be acquired from the cardiac chambers and aorta synchronously with the pressures recorded by the catheter (as a part of the patient's standard of care). After acquiring the ultrasound imaging data, the remainder of the heart catheterization will be completed by the attending cardiologist according to the patients' standard of care.

Timeline

• Start date: 2017-12-04
• Primary completion: 2020-09-18
• Completion: 2023-06-07
• First posted: 2017-08-10
• Last updated: 2024-05-29
• Results posted: 2024-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study