Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCSRome, ItalyContact: Cristina Aurigemma, M.D.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07016789
- Record updated
- 26 June 2025
- Original description
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.Read full original descriptionShow less
Cerebral Regional Oxygen Saturation During TAVI: A Prospective Comparison of Balloon-Expandable and Self-Expanding Valves
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.
Inclusion: Signed informed consent prior to any study-specific procedures; Diagnosis of severe degenerative aortic valve stenosis with echocardiographic criteria:; Mean gradient > 40 mm Hg, or; Jet velocity > 4.0 m/s, or; Aortic valve area (AVA) < 0.8 cm² (or AVA index < 0.5 cm²/m²); Symptomatic aortic stenosis defined as NYHA functional class ≥ II.
Exclusion: Cardiogenic shock or inotropic support required prior to the procedure; Chronic corticosteroid use; Participation in another investigational drug or device study; Symptomatic carotid artery disease or indication for carotid revascularization; Active neurodegenerative disease; ST-elevation myocardial infarction or cardiogenic shock within 48h before enrollment; Malignancy or comorbidities with life expectancy < 12 months; Stroke or transient ischemic attack within 6 months; Significant mixed valvular disease (e.g., severe mitral or tricuspid regurgitation); Active bacterial endocarditis or other active infections; Renal insufficiency (creatinine > 3.0 mg/dL) or dialysis dependency; Severe left ventricular dysfunction (LVEF < 30%); Age < 18 years; Contraindications as determined by anesthesiology screening; Contraindications to NIRS monitoring; Emergency TAVI due to decompensated AV stenosis; Inability to comply with the study protocol; Intracardiac mass, thrombus, or vegetation.