Radial versus femoral secondary access during TAVI
Radial Versus Femoral Secondary Access in Patients Undergoing TAVI
NA · University Heart Center Freiburg - Bad Krozingen · NCT07399392
This trial tests whether using the wrist (radial) artery instead of the groin (femoral) artery for the small secondary access during transfemoral TAVI lowers vascular complications in adults with severe aortic stenosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 434 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Heart Center Freiburg - Bad Krozingen (other) |
| Locations | 1 site (Freiburg im Breisgau) |
| Trial ID | NCT07399392 on ClinicalTrials.gov |
What this trial studies
Patients scheduled for transfemoral TAVI will receive the standard large femoral access for the valve and a second smaller access for the pigtail catheter either via the radial (wrist) artery or the femoral (groin) artery. The study compares vascular complications, bleeding events, and short-term procedural outcomes between the two secondary access approaches. Eligible adults (18+) who can give informed consent and have accessible radial and femoral arteries are included, while those with inaccessible access sites, hostile anatomy, or hemodynamic instability are excluded. The trial is carried out at the University Heart Center Freiburg using routine TAVI care with the alternative secondary access implemented per protocol.
Who should consider this trial
Good fit: Adults (18+) scheduled for transfemoral TAVI who can give informed consent and have suitable radial and femoral arteries are ideal candidates.
Not a fit: Patients with non-accessible radial or femoral arteries, hostile transfemoral anatomy, hemodynamic instability, or lack of capacity to consent are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, using radial secondary access could reduce vascular complications, bleeding, and recovery time after transfemoral TAVI.
How similar studies have performed: Observational studies and registry data have suggested radial secondary access may lower vascular complications compared with femoral access, but large randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Freiburg im Breisgau
- University Heart Center - Deparment for Cardiology and Angiology — Freiburg im Breisgau, Germany (RECRUITING)
Study contacts
- Study coordinator: Constantin von zur Muehlen, MD
- Email: constantin.vonzurmuehlen@uniklinik-freiburg.de
- Phone: +49 761 270 34415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: TAVI