Radial Versus Femoral Secondary Access in Patients Undergoing TAVI (RADIAL-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.

Study Overview

• Status: Recruiting
• Conditions: TAVI(Transcatheter Aortic Valve Implantation)
• Intervention / Treatment: Procedure: Radial TAVI; Procedure: femoral TAVI

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Constantin von zur Muehlen, MD; Phone Number: +49 761 270 34415; Email: constantin.vonzurmuehlen@uniklinik-freiburg.de

Study Locations

• Germany
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • University Heart Center - Deparment for Cardiology and Angiology
    • Contact: Constantin von zur Muehlen, MD; Phone Number: +49 761 270 34415; Email: constantin.vonzurmuehlen@uniklinik-freiburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 Radial; Group 1: patients with radial secondary arterial access	Procedure: Radial TAVI; patients will recieve the TAVI intervention via radial access
Active Comparator: Group 2 femoral; Group 2: patients with femoral secondary arterial access	Procedure: femoral TAVI; patients will recieve the TAVI intervention via femoral access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vascular and bleeding complications related to the secondary vascular access site	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Until 30 days after index procedure:	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	30 days

Collaborators and Investigators

• Sponsor: University Heart Center Freiburg - Bad Krozingen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-1058-S1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared IPD from clinical trials used for further scientific research will be stored in a secure processing environment and, depending on the request for secondary use, will be made accessible either as pseudonymised or anonymised datasets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No