Savvywire versus standard LV guidewires during transfemoral TAVI
SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation; a Prospective Registry (SAPPHIRE)
For people 50 and older having transfemoral TAVI, researchers will compare the Savvywire and standard LV guidewires to see if the Savvywire improves pacing and procedure-related blood flow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Catharina Ziekenhuis Eindhoven Academic / other |
| Locations | 1 site (Eindhoven, North Brabant) |
| Trial ID | NCT07366671 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of routine left-ventricular (LV) guidewires used during transfemoral TAVI procedures, comparing conventional LV guidewires with the newer Savvywire. Procedural details are collected retrospectively after consent is obtained post-procedure, and standard clinical follow-up data are gathered prospectively at about three months. All participants receive usual care; no experimental interventions are assigned. The goal is to document which wires are used and whether the Savvywire adds measurable procedural or hemodynamic value.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 or older who are accepted for transfemoral TAVI (including valve-in-valve and bicuspid cases) and can give written informed consent.
Not a fit: Patients planned for non-transfemoral TAVI, those with extreme aortic/root or iliofemoral tortuosity or very horizontal aortas, or those unable to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If the Savvywire shows advantages, patients may experience smoother pacing and improved procedural hemodynamics during TAVI, which could reduce complications or procedure time.
How similar studies have performed: Standard LV guidewires are well established and safe, but there is limited published evidence that specialized wires like the Savvywire provide additional pacing or hemodynamic benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 50 years * Accepted for transfemoral TAVI procedure by Heart team and TAVI team * Transfemoral TAVI procedure with balloon-expandable or self-expandable TAVI platform * Ability to understand and the willingness to provide written informed consent * Patients scheduled for valve-in-valve procedures can be included * Patients with bicuspid anatomy can be included Exclusion Criteria: * Patients planned for a non-transfemoral TAVI procedure * Extremely horizontal aorta (aortic root angle \>70 degrees) * Extreme tortuosity at the level of the iliofemoral arteries, abdominal and/or thoracic aorta * Inability to provide informed consent.
Where this trial is running
Eindhoven, North Brabant
- Catharina Hospital Eindhoven — Eindhoven, North Brabant, Netherlands (Recruiting)
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.