18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 23, 2017

Primary Completion Date

October 31, 2023

Study Completion Date

February 16, 2024

Conditions
Aortic Stenosis
Interventions
OTHER

18F-NaF

"At baseline a target dose of 125 MBq 18F-NaF will be administered intravenously to all subjects who will then undergo dual cardiac and respiratory-gated PET-CT imaging of the heart and aortic valve. 125ml of iodine-based contrast agent (iohexol \[Omnipaque™\]) will be given for the CT. Nitroglycerin will be given to increase the size of the coronary arteries and a possible dose of metoprolol may be given to control target heart rate.~Repeat contrast-enhanced CT of the heart and aortic valve will be conducted at Year 2 to investigate to investigate whether 18F-NaF activity predicts progression of calcification in prosthetic valves."

Trial Locations (1)

90048

Cedars-Sinai Medical Center, Los Angeles

All Listed Sponsors
lead

Cedars-Sinai Medical Center

OTHER

NCT03095313 - 18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes | Biotech Hunter | Biotech Hunter