This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation). The study uses a non-invasive monitoring system (NIRS) to track brain oxygenation (rSO₂) in real time.
The goal is to understand whether balloon-expandable, intra-annular self-expanding, or supra-annular self-expanding valves lead to different levels or patterns of cerebral oxygenation. This may help identify early warning signs for delayed hemodynamic recovery, stroke, or delirium.
Participants will be randomly assigned to receive one of:
A balloon-expandable valve (Group A), or
A self-expanding valve (Group B), with further randomization into:
Group B1: intra-annular valve (NAVITOR)
Group B2: supra-annular valve (EVOLUT)
The procedure, follow-up, and data collection will follow standard clinical practice. No experimental devices or drugs are used. Patients will not undergo any additional risk or burden beyond what is normally expected during TAVI.
The study is being conducted at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy, and aims to enroll 40 patients. No compensation is provided, and participation is voluntary.
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Parallel
Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C
DeviceContinuous bilateral cerebral oxygen saturation monitoring using near-infrared spectroscopy (NIRS) during TAVI. Sensors are placed on the forehead to record rSO₂ values at predefined timepoints. Device used: INVOS 5100C (Medtronic/Covidien).
Change in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI)
Cerebral rSO₂ will be monitored at six procedural timepoints using NIRS: pre-induction, start of procedure, pre-dilatation (if performed), valve deployment, lowest rSO₂ value during deployment, post-dilatation (if performed), and end of procedure. The primary outcome is the comparison of rSO₂ profiles between patients receiving balloon-expandable valves and those receiving self-expanding valves.
In-hospital all-cause mortality
Number of participants who die from any cause during the index hospitalization after TAVI.
In-hospital stroke incidence
Occurrence of stroke during the hospitalization period, as defined by VARC-3 criteria.
Incidence of postoperative delirium
Delirium will be assessed using CAM-ICU and RASS scales during the first three days post-TAVI or ICU stay.
Exploratory comparison of cerebral oxygen saturation across all three valve types
Exploratory analysis of cerebral rSO₂ trends and nadir values during TAVI among three groups: balloon-expandable (Group A), intra-annular self-expanding (Group B1), and supra-annular self-expanding valves (Group B2). The analysis will investigate whether different valve designs result in different cerebral oxygenation patterns.
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