Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)

Ki vehet részt

• Patient is at least 18 years of age at the time of screening
• Patient is scheduled to undergo elective transcatheter aortic valve implantation (TAVI) via transfemoral arterial access
• Patient is deemed suitable for transfemoral TAVI and large-bore vascular access closure by the local Heart Team
• Patient (or legally authorized representative) provides written informed consent prior to initiating any study-related procedures
• Patient is willing and able to comply with all specified study procedures, follow-up visits, and clinical evaluations

Ki nem vehet részt

• Concurrent participation in another interventional clinical trial investigating cardiovascular devices or drugs that could confound study endpoints
• Known active, unresolved local or systemic infection at the planned vascular access site
• Known severe allergy or hypersensitivity to bovine tissue, collagen, or any component of the study closure devices (Perclose ProGlide/ProStyle or Angio-Seal) that cannot be adequately premedicated
• Severe bleeding diathesis, active major bleeding, or absolute contraindication to standard periprocedural anticoagulation or antiplatelet therapy
• Planned TAVI procedure via non-femoral arterial access (e.g., transapical, transaortic, subclavian/axillary, or carotid access)
• Emergency or non-elective TAVI procedure
• Target main femoral artery vessel diameter, calcification, or tortuosity judged unsuitable for standard percutaneous large-bore vascular closure device deployment
• Patient is pregnant or breastfeeding
• Patient belongs to a vulnerable population (e.g., individuals deprived of liberty, under guardianship, or unable to give informed consent)