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

Deutsches Herzzentrum Muenchen450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Aortic Valve Stenosis

Interventions

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

Combined suture- and plug-based VCD strategy after TF-TAVI.

Combination of two ProGlides or ProStyles (Abbott Vascular).DEVICE

Pure suture-based VCD strategy after TF-TAVI.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Deutsches Herzzentrum München

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis.

The primary outcome measure is a combination of major or minor vascular and access-site-related complications or need for additional interventional (e.g. covered stent implantation) or surgical procedures related to vascular hemostasis according to updated VARC-3 criteria.

Time frame: In-hospital, in average three days

Secondary Outcomes

Major or minor vascular and access-site-related complications after TF-TAVI.

Combination of major or minor vascular and access-site-related complications after TF-TAVI according to VARC-3 criteria.

Time frame: At 30-day follow-up

Individual components of the primary endpoint, namely 1) major or minor vascular and access-site-related complications, 2) need for additional interventional or surgical procedures related to vascular hemostasis.

Individual components of the primary endpoint according to VARC-3 criteria.

Time frame: In-hospital (in average three days) and at 30-day follow-up

Unplanned use of endovascular stent and/or vascular surgery or other endovascular interventions at the puncture site.

Unplanned use of endovascular stent (e.g. covered stent) and/or vascular surgery or other endovascular interventions at the puncture site.

Time frame: In-hospital (in average three days) and at 30-day follow-up

Any bleedings.

Any type of bleedings according to VARC-3 criteria.

Time frame: In-hospital (in average three days) and at 30-day follow-up

Need for blood transfusions.

Data from ClinicalTrials.gov

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