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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Versus Femoral Secondary Access in Patients Undergoing TAVI
- ClinicalTrials.gov ID
- NCT07399392
- Acronym / sponsor ID
- RADIAL-TAVI / 25-1058-S1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Heart Center Freiburg - Bad KrozingenUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Radial | Active comparator | Procedure: Radial TAVIGroup 1: patients with radial secondary arterial access |
| Group 2 femoral | Active comparator | Procedure: femoral TAVIGroup 2: patients with femoral secondary arterial access |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for transfemoral TAVI
- Heart team agrees on eligibility of TAVI
- Written informed consent
- Age > 18 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial TAVIpatients will recieve the TAVI intervention via radial access | Procedure or surgery | Group 1 Radial |
| femoral TAVIpatients will recieve the TAVI intervention via femoral access | Procedure or surgery | Group 2 femoral |
Primary outcome
Vascular and bleeding complications related to the secondary vascular access site
Time frame: 30 days
1 secondary outcome
Until 30 days after index procedure:
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular and bleeding complications related to the secondary vascular access site (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.