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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jun 9, 2025

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ClinConnect Summary

The CROS-TAVI study is looking at how different types of heart valves used in a procedure called Transcatheter Aortic Valve Implantation (TAVI) affect the oxygen levels in the brain during the surgery. This is important because understanding brain oxygenation can help doctors spot problems like delayed recovery or even stroke. In this study, patients will be randomly assigned to receive either a balloon-expandable valve or a self-expanding valve, which is further divided into two types. Researchers will monitor brain oxygen levels using a safe, non-invasive method throughout the procedure.

To participate in this study, you should be between 65 and 74 years old and diagnosed with severe aortic valve stenosis, which means your heart’s aortic valve is narrowed and not functioning well. You must also be feeling symptoms related to this condition. However, some people may not be eligible, such as those with certain heart or brain conditions, or those who have had recent serious health issues. If you join the study, you can expect to undergo the standard TAVI procedure without any extra risks beyond what is normally involved. Participation is completely voluntary, and you won't receive any compensation for being part of the trial.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Symptomatic carotid artery disease or indication for carotid revascularization
• • Cardiogenic shock or inotropic support required prior to the procedure
• • Active neurodegenerative disease
• • Contraindications as determined by anesthesiology screening
• • Age \< 18 years
• • Contraindications to NIRS monitoring
• • ST-elevation myocardial infarction or cardiogenic shock within 48h before enrollment
• • Emergency TAVI due to decompensated AV stenosis
• • Malignancy or comorbidities with life expectancy \< 12 months
• • Inability to comply with the study protocol
• • Stroke or transient ischemic attack within 6 months
• • Renal insufficiency (creatinine \> 3.0 mg/dL) or dialysis dependency
• • Severe left ventricular dysfunction (LVEF \< 30%)
• • Significant mixed valvular disease (e.g., severe mitral or tricuspid regurgitation)
• • Intracardiac mass, thrombus, or vegetation
• • Chronic corticosteroid use
• • Participation in another investigational drug or device study
• • Active bacterial endocarditis or other active infections