Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-01 @ 5:37 PM
Study NCT ID:
NCT04274751
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2020-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation
Sponsor:
Ignacio J. Amat Santos
Organization:
Study Overview
Official Title:
Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation: The TRANSAX Study
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSAX
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: