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

Recruitingn/aAges 50 Years - anyAlldr Pim A.L. Tonino
NCT07366671 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 s

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Catharina Hospital Eindhoven
Eindhoven, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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