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

NCT ID: NCT05503199

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-04-18

Brief 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.

Detailed Description

Detailed information is provided elsewhere.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined suture- and plug-based VCD strategy

1 ProGlide or ProStyle + 1 Angio-Seal

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Pure suture-based VCD strategy

2 ProGlides or ProStyles

Group Type: EXPERIMENTAL

Combination of two ProGlides or ProStyles (Abbott Vascular).

Intervention Type: DEVICE

Pure suture-based VCD strategy after TF-TAVI.

Interventions

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

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

Intervention Type: DEVICE

Combination of two ProGlides or ProStyles (Abbott Vascular).

Pure suture-based VCD strategy after TF-TAVI.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Joner, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Tobias Rheude, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Locations

Deutsches Herzzentrum München

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

GE IDE No. T00122

Identifier Type: -

Identifier Source: org_study_id