NCT03015818

Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue. This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.

Conditions

• Aortic Bioprosthesis Structural Valve Dysfunction

Interventions

Type	Name	Description
OTHER	18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT	18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT

Timeline

• Start date: 2017-01-30
• Primary completion: 2019-05-03
• Completion: 2019-05-03
• First posted: 2017-01-10
• Last updated: 2020-01-18

Locations

1 site across 1 country: France