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

Study Overview
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Brief Summary
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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 Description
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Detailed information is provided elsewhere.

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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).
* Device: Combination of two ProGlides or ProStyles (Abbott Vascular).


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined suture- and plug-based VCD strategy<br>1 ProGlide or ProStyle + 1 Angio-Seal | Device: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).<br>* Combined suture- and plug-based VCD strategy after TF-TAVI.<br>|
| Experimental: Pure suture-based VCD strategy<br>2 ProGlides or ProStyles | Device: Combination of two ProGlides or ProStyles (Abbott Vascular).<br>* Pure suture-based VCD strategy after TF-TAVI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | In-hospital, in average three days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | In-hospital (in average three days) and at 30-day follow-up | 
| Any bleedings. | Any type of bleedings according to VARC-3 criteria. | In-hospital (in average three days) and at 30-day follow-up | 
| Need for blood transfusions. | Need for blood transfusions for vascular access-site-related bleedings or vascular complications. | In-hospital (in average three days) | 
| Percent diameter stenosis of vascular access vessel. | Percent diameter stenosis of vascular access vessel on post-procedural angiography. | Intra-procedural | 
| All-cause mortality. | All-cause mortality according to VARC-3 criteria. | In-hospital (in average three days) and at 30-day follow-up | 
| Length of post-procedural hospital stay. | Length of post-procedural hospital stay (days). | In-hospital (in average three days) | 
| Time from VCD application to complete hemostasis. | Time from VCD application to complete hemostasis (seconds). | Intra-procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation (TAVI), Vascular Closure Device