Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry

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.

NCT Number	NCT07016789
Lead Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions	Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic Changes
Enrollment	40 participants
Start Date	2025-06
Primary Completion	2026-04 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-06-26