TAVI(Transcatheter Aortic Valve Implantation)RADIAL-TAVINCT07399392
Radial Versus Femoral Secondary Access in Patients Undergoing TAVI
A study testing Radial TAVI and femoral TAVI in people with TAVI(Transcatheter Aortic Valve Implantation), run by University Heart Center Freiburg - Bad Krozingen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TAVI(Transcatheter Aortic Valve Implantation)
- What is being tested?
- Radial TAVI and femoral TAVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2025to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for transfemoral TAVI
- Heart team agrees on eligibility of TAVI
- Written informed consent
- Age > 18 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University Heart Center - Deparment for Cardiology and Angiology
Freiburg im Breisgau, 79106
About this study
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.
Read more
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.
- Being tested
- Radial TAVI, femoral TAVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial TAVIProcedure or surgery
patients will recieve the TAVI intervention via radial access
femoral TAVIProcedure or surgery
patients will recieve the TAVI intervention via femoral access
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Radial | Active comparator | Group 1: patients with radial secondary arterial access Receives: Procedure: Radial TAVI |
| Group 2 femoral | Active comparator | Group 2: patients with femoral secondary arterial access Receives: Procedure: femoral TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular and bleeding complications related to the secondary vascular access site
Measured: 30 days
Secondary outcomes (1)
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Jul 2025
- Primary completion15 Nov 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAVI(Transcatheter Aortic Valve Implantation)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Heart Center Freiburg - Bad Krozingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399392
- Sponsor's protocol ID
- 25-1058-S1
- Acronym
- RADIAL-TAVI
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.