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Completed

NCT Number: NCT04459208

Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

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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

Herzzentrum Leipzig

Leipzig, Germany

About this study

Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with an indication for transfemoral TAVI as judged by the local heart team.
  • Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
  • The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.

Exclusion criteria

  • Vascular access site anatomy not suitable for percutaneous vascular closure.
  • Vascular access site complications prior to the TAVI procedure.
  • Known allergy or hypersensitivity to any VCD component.
  • Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
  • Absence of computed tomographic data of the access site before the procedure.
  • Systemic infection or a local infection at or near the access site.
  • Life expectancy of less than 6 months due to non-cardiac conditions.
  • Patient cannot adhere to or complete the investigational protocol for any reason.
  • Pregnant or nursing subjects.
  • Participation in any other interventional trial.

Treatment and study plan

Manta

Device

plug-based vascular closure

ProGlide

Device

suture-based vascular closure

Primary outcomes

  1. Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition

    Time frame: up to 7 days

    Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition

Secondary outcomes

  1. Rate of access-site or access-related vascular injury

    Time frame: 30 days

    Rate of access-site or access-related vascular injury

  2. Rate of major access-site or access-related vascular injury

    Time frame: up to 7 days and at 30 days

    Rate of major access-site or access-related vascular injury

  3. Rate of minor access site or access-related vascular injury

    Time frame: up to 7 days and at 30 days

    Rate of minor access site or access-related vascular injury

  4. Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria

    Time frame: up to 7 days and at 30 days)

    Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria

  5. all-cause death

    Time frame: up to 7 days and 30-day

    all-cause death

  6. death attributed to access-site or access-related complications

    Time frame: up to 7 days and 30-day

    death attributed to access-site or access-related complications

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

    Time frame: up to 7 days

    Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other

  8. access-site or access-related disabling/life- threatening bleeding according to BARC

    Time frame: up to 7 days and 30-day

    access-site or access-related disabling/life- threatening bleeding according to BARC

  9. access-site or access-related major bleeding according to BARC

    Time frame: up to 7 days and 30-day

    access-site or access-related major bleeding according to BARC

  10. access-site or access-related minor bleeding according to BARC

    Time frame: up to 7 days and 30-day

    access-site or access-related minor bleeding according to BARC

  11. Need for blood transfusion for access-site or access-related bleeding or vascular complications

    Time frame: up to 7 days

    Need for blood transfusion for access-site or access-related bleeding or vascular complications

  12. Total number of blood transfusions because of access-site or access-related bleeding

    Time frame: up to 7 days

    Total number of blood transfusions because of access-site or access-related bleeding

  13. Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis

    Time frame: 24 hours

    Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis

  14. Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment

    Time frame: 24 hours

    Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment

  15. Length of postprocedural hospital stay

    Time frame: up to 7 days

    Length of postprocedural hospital stay

  16. Time to hemostasis, defined as the time from VCD application to complete hemostasis

    Time frame: 24 hours

    Time to hemostasis, defined as the time from VCD application to complete hemostasis

  17. Need and number of additional unplanned VCDs

    Time frame: 24 hours

    Need and number of additional unplanned VCDs

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

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Registry information

Acronym: CHOICE-CLOSURE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2020
Registry last updated
Sep 29, 2021

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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