Assessing the impact of leaflet thrombosis on aortic valve degeneration after TAVI
The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration
St. Antonius Hospital · NCT05758662
This study is trying to see how leaflet thrombosis affects the long-term health of aortic valves in patients who have had a transcatheter aortic valve replacement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital (other) |
| Locations | 4 sites (Copenhagen and 3 other locations) |
| Trial ID | NCT05758662 on ClinicalTrials.gov |
What this trial studies
This multicentre observational study aims to evaluate the differences in bioprosthetic micro-calcification activity as an early marker of transcatheter aortic valve degeneration. It will compare patients with and without subclinical leaflet thrombosis five years after undergoing transcatheter aortic valve implantation (TAVI). The study will utilize 18F-sodium fluoride PET-CT imaging to detect micro-calcification and assess the impact of different prosthesis types, specifically intra-annular versus supra-annular valves, on valve health. By understanding these factors, the study seeks to provide insights into the long-term outcomes of TAVI patients.
Who should consider this trial
Good fit: Ideal candidates are patients who successfully underwent TAVI with Sapien or CoreValve Evolut prostheses approximately five years ago.
Not a fit: Patients who have undergone temporary or chronic oral anticoagulation after TAVI or have severe renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for patients undergoing TAVI, potentially reducing the risk of valve degeneration.
How similar studies have performed: While the specific approach of using 18F-NaF PET to assess valve degeneration is novel, related studies have shown the importance of monitoring bioprosthetic valve health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Temporary or chronic oral anticoagulation use after TAVI * Known severe renal insufficiency * Known severe paravalvular regurgitation * History of valve-in-valve procedure * History of aortic valve re-intervention (including percutaneous paravalvular leak closure)
Where this trial is running
Copenhagen and 3 other locations
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- St. Antonius Hospital — Nieuwegein, Utrecht, Netherlands (RECRUITING)
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
- University of Edinburgh — Edinburgh, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Dirk-Jan van Ginkel, MD
- Email: d.van.ginkel@antoniusziekenhuis.nl
- Phone: +31 (0)88 320 66 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Stenosis, TAVI, TAVR, Subclinical Leaflet Thrombosis, Bioprosthetic Valve Deterioration, Intra-annular, Supra-annular