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NCT Number: NCT05503199

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

About this study

Detailed information is provided elsewhere.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Combination of two ProGlides or ProStyles (Abbott Vascular).

Device

Pure suture-based VCD strategy after TF-TAVI.

Primary outcomes

  1. Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis.

    Time frame: In-hospital, in average three days

    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.

Secondary outcomes

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

    Time frame: At 30-day follow-up

    Combination of major or minor vascular and access-site-related complications after TF-TAVI according to VARC-3 criteria.

  2. 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.

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

    Individual components of the primary endpoint according to VARC-3 criteria.

  3. Unplanned use of endovascular stent and/or vascular surgery or other endovascular interventions at the puncture site.

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

    Unplanned use of endovascular stent (e.g. covered stent) and/or vascular surgery or other endovascular interventions at the puncture site.

  4. Any bleedings.

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

    Any type of bleedings according to VARC-3 criteria.

  5. Need for blood transfusions.

    Time frame: In-hospital (in average three days)

    Need for blood transfusions for vascular access-site-related bleedings or vascular complications.

  6. Percent diameter stenosis of vascular access vessel.

    Time frame: Intra-procedural

    Percent diameter stenosis of vascular access vessel on post-procedural angiography.

  7. All-cause mortality.

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

    All-cause mortality according to VARC-3 criteria.

  8. Length of post-procedural hospital stay.

    Time frame: In-hospital (in average three days)

    Length of post-procedural hospital stay (days).

  9. Time from VCD application to complete hemostasis.

    Time frame: Intra-procedural

    Time from VCD application to complete hemostasis (seconds).

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Official study title

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

Acronym: ACCESS-TAVI

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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