Comparing short and long aspirin therapy after heart 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 clinical trial aims to determine whether a shorter duration of aspirin treatment (3 months) after transcatheter aortic valve replacement (TAVI) is as safe and effective as the standard longer duration (12 months). The study will involve adult patients who have successfully undergone TAVI for symptomatic aortic stenosis and have no other indications for long-term antiplatelet therapy. Participants will be monitored for bleeding and cardiovascular events through regular follow-ups and diary entries during the study period. The goal is to assess if reducing aspirin treatment can lower bleeding risks without increasing cardiovascular complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18
* Male or, post-menopausal -with no menses for 12 months without an alternative medical cause- or permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy- female
* Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33

  * Successful access, delivery of the device, and retrieval of the delivery system
  * Correct positioning of a single prosthetic heart valve into the proper anatomical location
  * Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access-related, or cardiac structural complication
* Written informed consent
* Social security affiliated
* French speaking

Exclusion Criteria:

* Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI3
* Alternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches
* TAVI for other indications than aortic stenosis (pure aortic regurgitation)
* Valve in valve TAVI
* Any indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease…) at any time prior to randomization
* Any indication for oral anticoagulation: (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism, ventricular thrombus…) at any time prior to randomization
* Patients on long term antiplatelet or anticoagulant therapy prior to TAVI for any other indication than TAVI
* Any contraindication to long term antiplatelet therapy (e.g. allergy or intolerance to aspirin, major bleeding, high bleeding risk, thrombocytopenia \< 50 000, major haemostasis disorder…)
* Women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy-
* Adult with protective measures (tutorship, curatorship)
* Patients considered as vulnerable by the investigators because of medical, psychological or social conditions:

  * Patients with known or discovered severe cognitive impairment
  * Patients with treated or untreated severe psychological or psychiatric conditions
  * Patients with uncorrected severe hearing or visual handicap
  * Patients with addictive alcohol, drug or substance abuse
  * Patients with protective measures (guardianship, tutorship, curatorship)
  * Any other condition considered by the investigators as not warranting informed consent

Where it's running

• Caen University Hospital
  Caen, France Recruiting

Study contacts

• Study coordinator: Farzin Beygui, MD,PhD
• Email: beygui-f@chu-caen.fr
• Phone: +33231063350

Similar studies

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

• SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI

  This trial tests whether the Double-TAP post-dilatation strategy can reduce HALT and improve valve function in patients 70 or older undergoing balloon-expandable TAVI.

  Recruiting Erasmus Medical Center · Düsseldorf and 4 other locations · NCT07872020

• Low-dose Colchicine after TAVR to help prevent valve clots

  This study tests whether taking a low dose of colchicine for 12 months after transcatheter aortic valve replacement can reduce valve thrombosis compared with standard care alone.

  Recruiting China National Center for Cardiovascular Diseases · Beijing · NCT07411768

• Transcatheter Mitral and Tricuspid Interventions and Cardiac MRI Registry

  This study will collect imaging and clinical data from adults undergoing transcatheter mitral or tricuspid procedures to see how their heart structure and function change over time using MRI and advanced ultrasound.

  Recruiting Centro Cardiologico Monzino · Milan, Milan · NCT07370467

• Evaluation of the Point-Guard device during heart valve replacement

  This study is testing a new device called Point-Guard to see if it can help prevent brain problems during heart valve replacement surgery.

  Recruiting Transverse Medical, Inc. · Clayton, Victoria · NCT06962371

• Single versus Dual Perclose Device Closure for Large-Bore Femoral Access in TAVR

  This will test whether using one Perclose device instead of two closes large-bore femoral access faster and with similar or fewer complications in people having transfemoral TAVR.

  Recruiting Wake Forest University Health Sciences · Milwaukee, Wisconsin · NCT06871774

• Assessing coronary artery disease in patients undergoing TAVI

  This study is testing whether a non-invasive way to check for heart artery problems is better than the usual invasive method for patients with severe aortic stenosis who are getting a new heart valve.

  Recruiting Insel Gruppe AG, University Hospital Bern · Bern · NCT06559332

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.