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

Aortic Valve Stenosis Clinical Trial

— ACCESS-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05503199
• Other study ID #: GE IDE No. T00122
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: April 18, 2024

Study information

• Verified date: April 2024
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Detailed information is provided elsewhere.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 18, 2024
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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.
• Combination of two ProGlides or ProStyles (Abbott Vascular).
Pure suture-based VCD strategy after TF-TAVI.

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

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