Short versus long antiplatelet therapy after TAVI

Phase 1

• Conditions: MedDRA version: 20.1Level: LLTClassification code: 10041974Term: Stenosis aortic valve Class: 10007541; All adult patients with successful transfemoral trans-aortic valve implantation (TAVI ) for symptomatic aortic stenosis (AS) with no other indication for long term antiplatelet or anticoagulant therapy; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-508208-40-00
• Lead Sponsor: Centre Hospitalier Universitaire De Caen Normandie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

•Age = 18, •Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33 oSuccessful access, delivery of the device, and retrieval of the delivery system oCorrect positioning of a single prosthetic heart valve into the proper anatomical location oFreedom 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, •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

Exclusion Criteria

•Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI, •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-, •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…), •Adult with protective measures (tutorship, curatorship)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified