Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry (NCT07016789) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry
Italy40 participantsStarted 2025-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI)
Timeframe: Intraoperative, from pre-induction to end of TAVI procedure (approximately 60-90 minutes)