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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04274751
Acronym
TRANSAX
Enrollment
75
Registered
2020-02-18
Start date
2019-07-01
Completion date
2020-06-30
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter aortic valve Implantation (TAVI), Transaxillary approach

Brief summary

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

Detailed description

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.

Interventions

DEVICETranscatheter aortic valve implantation

Transcatheter aortic valve implantation

Sponsors

Boston Scientific Corporation
CollaboratorINDUSTRY
Ignacio J. Amat Santos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
30-day death, stroke or embolic events, PVE or sepsis30 dayCombined endpoint of death, stroke or embolic events, PVE or sepsis at 30-day follow up.
1-year death, stroke or embolic events, PVE or sepsis1 yearCombined endpoint of death, stroke or embolic events, PVE or sepsis at 1-year follow up.
Intraprocedural Vascular complicationsIntraproceduralIntraprocedural Vascular complications
In-hospital Vascular complications7-daysIn-hospital Vascular complications

Secondary

MeasureTime frameDescription
Short term complications related to the approach.30-daysShort term complications related to the approach.
Mid term complications related to the approach.1-yearMid term complications related to the approach.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026