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

University Heart Center Freiburg - Bad Krozingen

Status: Enrolling

Conditions: TAVI(Transcatheter Aortic Valve Implantation)

Treatments: Procedure: femoral TAVI; Procedure: Radial TAVI

Study type: Interventional

Funder types: Other

Identifiers

NCT07399392

25-1058-S1

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Group 1 Radial

Active Comparator group

Description:

Group 1: patients with radial secondary arterial access

Treatment:

Procedure: Radial TAVI

Group 2 femoral

Active Comparator group

Description:

Group 2: patients with femoral secondary arterial access

Treatment:

Procedure: femoral TAVI