18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Stenosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
Description
This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses...
This five-year pilot study will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve age and valve type, and 2) subsequent degeneration of aortic valve bioprostheses based upon clinical, echocardiographic and CT parameters. Techniques that can identify specific increases in calcification activity are therefore likely to provide important insights into predicting the longevity of TAVR valves and guidance towards subsequent interventions. Twenty patients whom have undergone either TAVR or surgical bioprosthetic aortic valve replacement will be invited to participate in an 18F-NaF PET scan (baseline) and CT scan imaging (baseline and Year 2). Baseline, Year 1 and 2 will also include clinical assessment, labs and echocardiograms. Telephone contact at Years 3, 4, and 5 will provide follow up for major cardiovascular adverse events.
Tracking Information
- NCT #
- NCT03095313
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Daniel S. Berman, MD Cedars-Sinai Medical Center
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