Status:
COMPLETED
Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
American Heart Association
Lantheus Medical Imaging
Conditions:
Cardiac Catheterization
Blood Pressure
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Be scheduled for a cardiac catheterization procedure
- Adult patients over the age of 21
- Acceptable baseline echocardiographic images in the supine position
- If a female of child-bearing potential, must have a negative pregnancy test
- Provide written informed consent
Exclusion
- Clinically unstable patients, e.g., those who are clinically in decompensated heart failure or having active chest pain or presenting for admission with an unstable anginal syndrome
- Patients in whom introduction of a catheter into the left ventricle is contraindicated or would potentially be dangerous, e.g., patients with active ventricular arrhythmias or with significant aortic valve stenosis where crossing the aortic valve may be difficult and not clinically necessary
- Patients with anatomic right-to-left, bi-directional, or transient right-to-left cardiac shunts where Definity could traverse as a bolus
- Patients with known hypersensitivity to Definity
- Females who are pregnant or nursing
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2019
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03243942
Start Date
June 1 2017
End Date
June 26 2019
Last Update
July 10 2019
Active Locations (1)
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1
Thomas Jefferson University and Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107