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

NCT07016789 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phase

Not applicable

Started

2025-06

Last updated

2025-06-26

Condition(s) studied

Aortic Stenosis DiseaseTAVI(Transcatheter Aortic Valve Implantation)Cerebral Oxygen SaturationHemodynamic Changes

Investigational drug(s) / intervention(s)

Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C

Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C: Continuous 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).

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Change in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI) — Intraoperative, from pre-induction to end of TAVI procedure (approximately 60-90 minutes)
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.

Trial sites (1)

Facility	City	Region	Status
Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome	Lazio

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07016789 on ClinicalTrials.gov ↗ ← All trials in Italy