Actively Recruiting
SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation
Led by dr Pim A.L. Tonino · Updated on 2026-03-11
300
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
Sponsors
D
dr Pim A.L. Tonino
Lead Sponsor
H
Haemonetics Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Catharina Hospital Eindhoven
Eindhoven, North Brabant, Netherlands, 5623EJ
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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