| Registry | NCT07399392, acronym RADIAL-TAVI |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 600 (Actual) |
| Sponsor | University Heart Center Freiburg - Bad Krozingen (Other) |
| Conditions | TAVI(Transcatheter Aortic Valve Implantation) |
| Interventions | Radial TAVI, femoral TAVI (Procedure) |
| Dates | start 2025-07-01, primary completion 2027-11-15 (estimated), completion 2028-12-31 (estimated), first posted 2026-02-10, last updated 2026-10-19 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for TAVI(Transcatheter Aortic Valve Implantation) All trials of Radial TAVI All trials of femoral 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1 Radial | Active comparator | Procedure: Radial TAVI | Group 1: patients with radial secondary arterial access |
| Group 2 femoral | Active comparator | Procedure: femoral TAVI | Group 2: patients with femoral secondary arterial access |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| University Heart Center - Deparment for Cardiology and Angiology | Freiburg im Breisgau | Germany |