Assessing the impact of leaflet thrombosis on aortic valve degeneration after TAVI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.