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

NCT07016789 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-26

No results posted yet for this 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.

Conditions

  • Aortic Stenosis Disease
  • TAVI(Transcatheter Aortic Valve Implantation)
  • Cerebral Oxygen Saturation
  • Hemodynamic Changes

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Cristina Aurigemma · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016789 on ClinicalTrials.gov