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Recruiting NCT07399392

Radial Versus Femoral Secondary Access in Patients Undergoing TAVI

No phase Interventional TAVI(Transcatheter Aortic Valve Implantation)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radial TAVI, femoral TAVI.
Who it may be relevant to
Registry conditions: TAVI(Transcatheter Aortic Valve Implantation). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Severe symptomatic aortic stenosis (AS) with a high gradient is associated with a poor prognosis if not treated with valve replacement. Transcatheter aortic valve implantation has been shown in large randomized trials to be a safe and effective treatment option for patients at low, intermediate, or high risk. Transfemoral access for heart valve replacement is by far the most commonly used approach, as it is relatively easy to control and has a low complication rate compared to other access routes. The TAVI procedure requires two arterial access points: one with a large lumen for the TAVI prosthesis via the femoral artery, and a smaller second one for a pigtail catheter that guides the TAVI prosthesis into the optimal position. This secondary access is most often via a second artery. Vascular complications are the most commonly observed complications in transfemoral TAVI and are associated with poorer procedural outcomes. Recent data suggest that secondary vascular access via the radial artery may contribute to a reduction in vascular complications after TAVI. In patients undergoing coronary angiography and/or percutaneous coronary intervention, radial access has become the preferred strategy due to its proven reduction in vascular complications compared to femoral access. The use of radial access is associated with a lower incidence of vascular complications compared to femoral access. Recent non-randomized data suggest that radial access may be a safer alternative to traditional femoral access as a secondary arterial access in transfemoral TAVI. However, non-randomized retrospective comparisons are subject to selection bias and underreporting of complications. Therefore, a prospective randomized trial is needed to evaluate the value of radial access for secondary arterial access in patients undergoing transfemoral TAVI.

Interventions

  • Procedure Radial TAVI
    patients will recieve the TAVI intervention via radial access
  • Procedure femoral TAVI
    patients will recieve the TAVI intervention via femoral access

Primary outcome measures

  • Vascular and bleeding complications related to the secondary vascular access site [Time frame: 30 days]
Secondary outcome measures (1)
  • Until 30 days after index procedure: [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Patients scheduled for transfemoral TAVI
  • Heart team agrees on eligibility of TAVI
  • Written informed consent
  • Age > 18 years

Exclusion criteria

  • Non accessible radial arteries as judged by the TAVI team
  • Non accessible femoral arteries as judged by the TAVI team
  • Foreseeable problems to achieve primary transfemoral access (hostile access)
  • Hemodynamic instability or cardiogenic shock
  • Currently participating in an investigational drug or another device study
  • Lack of capability to give informed consent
  • Patient refuses TAVI

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • University Heart Center - Deparment for Cardiology and Angiology — Freiburg im Breisgau

Identifiers

NCT: NCT07399392 · 25-1058-S1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗