NCT07366671 SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation
| NCT ID | NCT07366671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | dr Pim A.L. Tonino |
| Condition | TAVI(Transcatheter Aortic Valve Implantation) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-01-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT07366671 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying TAVI(Transcatheter Aortic Valve Implantation). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07366671 currently recruiting?
Yes, NCT07366671 is actively recruiting participants. Visit ClinicalTrials.gov or contact dr Pim A.L. Tonino to inquire about joining.
Where is the NCT07366671 trial being conducted?
This trial is being conducted at Eindhoven, Netherlands.
Who is sponsoring the NCT07366671 clinical trial?
NCT07366671 is sponsored by dr Pim A.L. Tonino. The trial plans to enroll 300 participants.