Status:
RECRUITING
Short Versus Long Antiplatelet Therapy After TAVI
Lead Sponsor:
University Hospital, Caen
Conditions:
Transcatheter Aortic Valve Replacement
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months (short treatment regimen) after percutaneous aortic valve replacement is as safe and efficient ...
Detailed Description
INTRODUCTION AND RATIONALE Aortic stenosis (AS) is the most common heart valve disease requiring intervention among elderly patients. Surgical aortic valve replacement which was the only curative trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT06518317
Start Date
November 21 2024
End Date
January 1 2029
Last Update
March 26 2025
Active Locations (1)
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1
Caen University Hospital
Caen, France, 14990