RecruitingNCT07366671

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

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation; a Prospective Registry (SAPPHIRE)


Sponsor

dr Pim A.L. Tonino

Enrollment

300 participants

Start Date

Jan 12, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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.

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Locations(1)

Catharina Hospital Eindhoven

Eindhoven, North Brabant, Netherlands

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NCT07366671


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