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

NCT05503199 | Completed DMC

• 1 other identifier: GE IDE No. T00122
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation (TAVI); Vascular Closure Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

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

  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.

  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.

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

• Any bleedings.

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

• Need for blood transfusions.

  In-hospital (in average three days)

Study Arms (2)

Combined suture- and plug-based VCD strategy

EXPERIMENTAL

1 ProGlide or ProStyle + 1 Angio-Seal

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

Pure suture-based VCD strategy

EXPERIMENTAL

2 ProGlides or ProStyles

Device: Combination of two ProGlides or ProStyles (Abbott Vascular).

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.

Combined suture- and plug-based VCD strategy

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

Pure suture-based VCD strategy after TF-TAVI.

Pure suture-based VCD strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (1)

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Michael Joner, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

• Tobias Rheude, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 16, 2022
• Study Start: October 1, 2022
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)