Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation (ACCESS-TAVI)

German Heart Center Munich

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).; Device: Combination of two ProGlides or ProStyles (Abbott Vascular).

Study type: Interventional

Funder types: Other

Identifiers

NCT05503199

GE IDE No. T00122

Details and patient eligibility

About

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.

Full description

Detailed information is provided elsewhere.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Combined suture- and plug-based VCD strategy

Experimental group

Description:

1 ProGlide or ProStyle + 1 Angio-Seal

Treatment:

Device: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).

Pure suture-based VCD strategy

Experimental group

Description:

2 ProGlides or ProStyles

Treatment:

Device: Combination of two ProGlides or ProStyles (Abbott Vascular).