Savvywire versus standard LV guidewires during transfemoral TAVI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Catharina Hospital Eindhoven
  Eindhoven, North Brabant, Netherlands Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.