SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

The goal of this observational study is to document which LV-guidewires are used during a TAVI (Transcatheter Aortic Valve Implantation) procedure and how their different functions perform. A TAVI procedure is a minimally invasive treatment for aortic stenosis, where a new heart valve is inserted through a blood vessel in the groin. During this procedure, a wire (specifically, an LV-guidewire) is used to place the new heart valve. For this purpose, a regular LV-guidewire or a newer LV-guidewire with extra features, the Savvywire, can be used. All of these wires work well, are safe, and are already used in daily medical practice. Researchers will compare these LV-guidewires to see if the Savvywire adds additional value. Patients aged 50 or older who undergo a TAVI procedure via the femoral artery (blood vessel in the groin) can participate. Participants will receive the usual care and standard follow-up, only their data will be collected and analyzed.

NCT Number	NCT07366671
Lead Sponsor	dr Pim A.L. Tonino Collaborators: Haemonetics Corporation
Conditions	TAVI(Transcatheter Aortic Valve Implantation), Aortic Valve Disease
Enrollment	300 participants
Start Date	2026-01-12
Primary Completion	2027-12 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-11