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NCT Number: NCT07399392

Radial Versus Femoral Secondary Access in Patients Undergoing TAVI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Heart Center - Deparment for Cardiology and Angiology

Freiburg im Breisgau, 79106, Germany

Location status: Recruiting

Location contact

Constantin von zur Muehlen, MD

CONTACT

[email protected]

+49 761 270 34415

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Radial TAVI

Procedure

patients will recieve the TAVI intervention via radial access

femoral TAVI

Procedure

patients will recieve the TAVI intervention via femoral access

Primary outcomes

  1. Vascular and bleeding complications related to the secondary vascular access site

    Time frame: 30 days

Secondary outcomes

  1. Until 30 days after index procedure:

    Time frame: 30 days

    • cardiovascular mortality
    • non-cardiovascular mortality
    • mortality related to vascular and bleeding complications
    • Incidence of new neurological events after randomization
    • Vascular complications at 30 days
    • Bleeding complications at 30 days
    • Incidence of acute kidney injury

Study contacts

Contact information is provided by the study sponsor or research team.

Constantin von zur Muehlen, MD

CONTACT

[email protected]

+49 761 270 34415

Sponsors and collaborators

Lead sponsor

University Heart Center Freiburg - Bad Krozingen

Other

Registry information

Acronym: RADIAL-TAVI

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Jun 2, 2026

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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