Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation

Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial

The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.

Detailed information is provided elsewhere.

Inclusion Criteria:

• Age ≥ 18 years and able to give consent
• Patients with an indication for TF-TAVI as judged by the local multi-disciplinary heart team
• Feasibility of transfemoral access route using commercially available transcatheter heart valves and delivery systems
• Written informed consent

Exclusion Criteria:

• Vascular access site anatomy not suitable for percutaneous vascular closure device
• Vascular access site complications prior to the TAVI procedure
• Known allergy or hypersensitivity to any component of the VCD
• Active bleeding or bleeding diathesis
• Absence of computed tomographic data of the access site before the procedure
• Systemic infection or local infection at or near the access site
• Limited long-term prognosis due to other comorbid conditions
• Patient cannot adhere to or complete the trial protocol for any reason
• Pregnancy
• Participation in any other interventional trial
• Patients with mechanical heart valves in mitral position
• Patients with elevated international normalized ratio (INR) due to oral anticoagulation therapy requiring reversal of vitamin K antagonists prior to TAVI using prothrombin complex concentrate