Personalized antithrombotic therapy for patients after aortic valve replacement

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 trial investigates the effectiveness of CT-guided antithrombotic therapy compared to standard lifelong single antiplatelet therapy in patients who have undergone transcatheter aortic valve implantation (TAVI) and do not require anticoagulants. The study aims to assess the presence of thrombosis on the newly implanted valve using a 4D CT scan three months post-procedure. Based on the scan results, patients may receive tailored antithrombotic therapy with apixaban, potentially reducing thromboembolic events while minimizing bleeding risks. This approach seeks to improve patient outcomes following TAVI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Successful TAVI (according to the VARC-3 criteria)10 with any approved device
* Ability to understand and to comply with the study protocol
* Written informed consent

Exclusion Criteria:

* Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)
* Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)
* Creatinine clearance \<15 mL/min (based on the CKD-EPI formula) or on renal replacement therapy

Where it's running

• St. Antonius Hospital
  Nieuwegein, Netherlands Recruiting

Study contacts

• Study coordinator: Christiaan Overduin
• Email: c.overduin@antoniusziekenhuis.nl
• Phone: +31883200931

Similar studies

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

• 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.

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• Noninvasive ECG Monitoring to Support Early Discharge After TAVI for Conduction Disorders

  A noninvasive ECG monitoring approach is tested to see if it safely allows patients with conduction issues after TAVI to go home earlier.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona · NCT07456280

• FAPI-PET imaging to see heart tissue changes after TAVI for aortic stenosis

  Using FAPI-PET scans, doctors will see if heart scarring and function improve after TAVI in people with severe aortic stenosis compared with those treated with medication alone.

  Recruiting RenJi Hospital · Shanghai · NCT07335900

• Registry for patients with severe aortic valve stenosis undergoing TAVR with Myval valve

  This study is testing how often heart rhythm problems happen and if patients need a pacemaker after getting a new heart valve through TAVR using the Myval valve.

  Recruiting Hospital Clínico Universitario de Valladolid · Valladolid, Valladolid · NCT06917066

• Comparing heart valve prostheses for treating aortic stenosis

  This study is testing how well different types of heart valve replacements work for people with severe aortic stenosis, especially those with smaller heart openings.

  Recruiting at 2 sites IRCCS Policlinico S. Donato · Bari, Apulia and 1 other locations · NCT06859255

• Evaluating treatment options for aortic valve stenosis

  This study is testing how different treatments for aortic valve stenosis, like surgery and other options, affect patients' quality of life and survival.

  Recruiting St. Antonius Hospital · Nieuwegein · NCT06168123

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.