Aortic Stenosis Disease, Cerebral Oxygen Saturation, Hemodynamic Changes, TAVI(Transcatheter Aortic Valve Implantation)
Conditions
Keywords
TAVI, Aortic Valve Stenosis, Cerebral Oxygen Saturation, NIRS, Balloon-Expandable Valve, Self-Expanding Valve
Brief 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.
Detailed description
This is a prospective, randomized, single-center, interventional clinical study conducted at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome, Italy. The study aims to investigate differences in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI) using different transcatheter heart valve (THV) technologies. Aortic valve stenosis (AVS) is the most common valvular disease in the elderly, and TAVI has become a widely accepted therapeutic option in high-, intermediate-, and low-risk patients. However, the rapid ventricular pacing, balloon dilatation, and valve deployment involved in TAVI may induce transient cerebral hypoperfusion. This study utilizes near-infrared spectroscopy (NIRS) as a non-invasive method to monitor cerebral oxygenation in real-time during the procedure. The primary objective is to evaluate the variation in rSO₂ during specific procedural phases and determine whether the type of valve used (balloon-expandable vs. self-expanding) impacts cerebral perfusion. A secondary aim is to identify a potential threshold value of rSO₂ below which prolonged hemodynamic recovery may occur. The study also explores the association between cerebral desaturation and clinical outcomes such as in-hospital mortality, stroke, and postprocedural delirium. Patients with symptomatic severe aortic stenosis meeting specific inclusion/exclusion criteria will be enrolled and randomized 1:1 to receive: Group A: A balloon-expandable valve (SAPIEN platform, Edwards Lifesciences) Group B: A self-expanding valve (SEV) Patients in Group B will be further randomized to receive: Group B1: Intra-annular SEV (NAVITOR, Abbott) Group B2: Supra-annular SEV (EVOLUT, Medtronic) Cerebral rSO₂ will be monitored bilaterally using INVOS 5100C NIRS sensors placed on the forehead. Measurements will be recorded at six procedural time points: baseline (pre-induction), start of procedure, during pre-dilatation (if performed), at valve deployment, at the lowest rSO₂ during deployment, post-dilatation (if performed), and end of procedure. Neurocognitive status will be assessed pre-procedure using the Mini-Mental State Examination (MMSE). Postoperative delirium will be monitored using the CAM-ICU and RASS scales. Clinical and procedural data, including rapid ventricular pacing parameters, valve type, and any need for resheathing, will also be recorded. The primary endpoint is the comparison of mean nadir rSO₂ values between balloon-expandable and self-expanding valve groups. Exploratory analyses will evaluate differences among all three groups (A, B1, B2). Secondary endpoints include in-hospital death, stroke, and delirium incidence. A total of 40 patients will be enrolled (20 in Group A, 10 in B1, 10 in B2). The study is no-profit, does not involve investigational drugs or unapproved devices, and all THVs used are CE-marked and clinically approved. The protocol has been approved by the local ethics committee (CET Lazio Area 3, ID 7257). The findings of this study may provide novel insights into the role of cerebral oxygenation monitoring during TAVI and contribute to optimizing valve selection and procedural strategies to improve neurologic and hemodynamic outcomes.
Interventions
DEVICENear-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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized in a 1:1 ratio to receive either a balloon-expandable valve (Group A) or a self-expanding valve (Group B). Patients randomized to Group B will undergo a second randomization to receive either: an intra-annular SEV (Group B1 - NAVITOR), or a supra-annular SEV (Group B2 - EVOLUT). Patients will be randomized in a 1:1 ratio to receive either a balloon-expandable valve (Group A) or a self-expanding valve (Group B). Patients randomized to Group B will undergo a second randomization to receive either: an intra-annular SEV (Group B1 - NAVITOR), or a supra-annular SEV (Group B2 - EVOLUT).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital all-cause mortality | From procedure to hospital discharge (up to 14 days) | Number of participants who die from any cause during the index hospitalization after TAVI. |
| In-hospital stroke incidence | From procedure to hospital discharge (up to 14 days) | Occurrence of stroke during the hospitalization period, as defined by VARC-3 criteria. |
| Incidence of postoperative delirium | First 3 days after the procedure or until discharge from ICU | Delirium will be assessed using CAM-ICU and RASS scales during the first three days post-TAVI or ICU stay. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory comparison of cerebral oxygen saturation across all three valve types | Intraoperative, from pre-induction to end of TAVI procedure (approximately 60-90 minutes) | Exploratory analysis of cerebral rSO₂ trends and nadir values during TAVI among three groups: balloon-expandable (Group A), intra-annular self-expanding (Group B1), and supra-annular self-expanding valves (Group B2). The analysis will investigate whether different valve designs result in different cerebral oxygenation patterns. |
Countries
Italy
Contacts
Primary ContactCristina Aurigemma, M.D.
Outcome results
None listed