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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).; Device: Combination of two ProGlides or ProStyles (Abbott Vascular).

Detailed Description

Detailed information is provided elsewhere.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80636
      • Deutsches Herzzentrum München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Principal Investigator: Michael Joner, MD, Deutsches Herzzentrum München; Principal Investigator: Tobias Rheude, MD, Deutsches Herzzentrum München

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): April 18, 2024
• Study Completion (Actual): April 18, 2024

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; Vascular Closure Device; Transcatheter Aortic Valve Implantation (TAVI)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: GE IDE No. T00122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No