The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago
• Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography
• Written informed consent
Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
St. Antonius Hospital
RECRUITING
Nieuwegein
United Kingdom
University of Edinburgh
NOT_YET_RECRUITING
Edinburgh
Contact Information
Primary
Dirk-Jan van Ginkel, MD
d.van.ginkel@antoniusziekenhuis.nl
+31 (0)88 320 66 48
Backup
Prof. J.M. ten Berg, MD, PhD, MSc
jurtenberg@gmail.com
Time Frame
Start Date: 2023-11-16
Estimated Completion Date: 2025-11
Participants
Target number of participants: 180
Treatments
Intra-annular
Patients with an intra-annular Sapien TAVI prosthesis
Supra-annular
Patients with a supra-annular CoreValve Evolut TAVI prosthesis
Related Therapeutic Areas
Sponsors
Collaborators: Medtronic, St. Antonius Research Fund
Leads: St. Antonius Hospital