NL-OMON53711RecruitingNot Applicable
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration - POPular PET TAVI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •o Successful TAVI with Sapien or CoreValve Evolut prosthesis about five years
- •o Able to undergo hybrid 18F-NaF PET-CT scan and transthoracic echocardiography
- •o Written informed consent
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •o Temporary or chronic oral anticoagulation use after TAVI
- •o Known severe renal insufficiency
- •o History of iodine contrast allergy
- •o Known severe paravalvular regurgitation
- •o History of valve-in-valve procedure
- •o History of aortic valve re-intervention (including percutaneous paravalvular
- •leak closure)
Investigators
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