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Completed

NCT Number: NCT04274751

Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation

Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

About this study

Aortic stenosis (AS) is the most frequently treated heart valve disease in our society. Transcatheter aortic valve implantation (TAVI) was originally described through an antegrade transeptal route by Cribier and colleagues in 2002. Because of the complexity of the procedure and risks of damaging the mitral apparatus, this approach was abandoned in favor of less challenging alternatives, with transfemoral (TF) route as primary option. Nevertheless, the TF approach is not feasible or of high risk in between 15 and 35% of the patients and vascular complications have been shown to be an independent predictor of death warranting alternative access techniques for TAVI. In this regard, the transapical, direct aortic, transcarotid, transcaval, and transubclavian/transaxillary (TSc) implantation routes currently serve as alternative access options. The TSc approach was initially used in selected cases. However, recent series suggest that TSc may provide better outcomes than alternative routes when TF is inadequate. Additionally, same studies suggest that, as compared to TF approach, TSc TAVI may present lower rate of vascular complications with comparable rates of other major outcomes despite the worse baseline profile of patients who are considered inappropriate for TF procedures. Moreover, fully-percutaneous TSc approach can be successfully performed with low rate of complications as was recently proposed by some authors. However, comparisons have been based in small series of cases, most of them with former iteration of TAVI devices, and a formal prospective comparison has never been performed. Therefore, our aim is to gather all cases of fully-percutaneous TSc and TF approaches for TAVI in Spain and Portugal and compare the standardized safety and efficacy endpoints through a matched analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.

Exclusion criteria

-

Treatment and study plan

Transcatheter aortic valve implantation

Device

Transcatheter aortic valve implantation

Primary outcomes

  1. 30-day death, stroke or embolic events, PVE or sepsis

    Time frame: 30 day

    Combined endpoint of death, stroke or embolic events, PVE or sepsis at 30-day follow up.

  2. 1-year death, stroke or embolic events, PVE or sepsis

    Time frame: 1 year

    Combined endpoint of death, stroke or embolic events, PVE or sepsis at 1-year follow up.

  3. Intraprocedural Vascular complications

    Time frame: Intraprocedural

    Intraprocedural Vascular complications

  4. In-hospital Vascular complications

    Time frame: 7-days

    In-hospital Vascular complications

Secondary outcomes

  1. Short term complications related to the approach.

    Time frame: 30-days

    Short term complications related to the approach.

  2. Mid term complications related to the approach.

    Time frame: 1-year

    Mid term complications related to the approach.

Sponsors and collaborators

Lead sponsor

Ignacio J. Amat Santos

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation: The TRANSAX Study

Acronym: TRANSAX

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2020
Registry last updated
Oct 26, 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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