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

Recruiting now

Conditions studied: TAVI(Transcatheter Aortic Valve Implantation), Aortic Valve Disease

In brief

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.

Key facts

Study ID

NCT07366671

Run by

dr Pim A.L. Tonino

People needed

300

Starts

2026-01-12

Expected to finish

2028-03-01

Last updated by the study team

2026-03-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Catharina Hospital Eindhoven — Eindhoven, North Brabant, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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