Aortic Stenosis DiseaseCROS-TAVINCT07016789
Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry
A study testing Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C in people with Aortic Stenosis Disease and TAVI(Transcatheter Aortic Valve Implantation), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation
- What is being tested?
- Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
Cristina Aurigemma, M.D., cristina.aurigemma@policlinicogemelli.it
About this study
Official title: Cerebral Regional Oxygen Saturation During TAVI: A Prospective Comparison of Balloon-Expandable and Self-Expanding Valves
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.
Read more
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.
Read the 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.
- Conditions
- Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic Changes
- Being tested
- Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C
- Keywords
- TAVI, Aortic Valve Stenosis, Cerebral Oxygen Saturation, NIRS, Balloon-Expandable Valve, Self-Expanding Valve
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopy monitoring (NIRS) INVOS 5100CDevice
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 group | Role | What they receive |
|---|---|---|
| Balloon-expandable valve (Group A) | Experimental | Participants in this arm will receive a balloon-expandable transcatheter heart valve (SAPIEN platform, Edwards Lifesciences). Cerebral oxygenation will be monitored during the TAVI procedure using NIRS. Receives: Device: Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C |
| Self-expanding intra-annular valve (Group B1) | Experimental | Participants in this arm will receive an intra-annular self-expanding valve (NAVITOR, Abbott). Cerebral rSO₂ will be monitored during TAVI using NIRS at predefined timepoints. Receives: Device: Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C |
| Self-expanding supra-annular valve (Group B2) | Experimental | Participants in this arm will receive a supra-annular self-expanding valve (EVOLUT, Medtronic). NIRS will be used to monitor cerebral oxygenation throughout the TAVI procedure. Receives: Device: Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI)
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.
Measured: Intraoperative, from pre-induction to end of TAVI procedure (approximately 60-90 minutes)
Secondary outcomes (3)
In-hospital all-cause mortality
Number of participants who die from any cause during the index hospitalization after TAVI.
Measured: From procedure to hospital discharge (up to 14 days)
In-hospital stroke incidence
Occurrence of stroke during the hospitalization period, as defined by VARC-3 criteria.
Measured: From procedure to hospital discharge (up to 14 days)
Incidence of postoperative delirium
Delirium will be assessed using CAM-ICU and RASS scales during the first three days post-TAVI or ICU stay.
Measured: First 3 days after the procedure or until discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Aurigemma, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016789
- Sponsor's protocol ID
- 7257
- Acronym
- CROS-TAVI
- Status last verified
- Apr 2025
- First submitted
- 29 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.
PubMed 33888385Iwata S, Ozaki M. Cerebral regional oxygen saturation as a predictive parameter for preoperative heart failure and delayed hemodynamic recovery in transcutaneous aortic valve implantation: a retrospective cohort study. J Clin Monit Comput. 2024 Aug;38(4):763-772. doi: 10.1007/s10877-024-01129-2. Epub 2024 Feb 4.
PubMed 38310595Suemori T, Horton SB, Bottrell S, Skowno JJ, Davidson A. Changes in cerebral oxygen saturation and haemoglobin concentration during paediatric cardiac surgery. Anaesth Intensive Care. 2017 Mar;45(2):220-227. doi: 10.1177/0310057X1704500212.
PubMed 28267944Uysal S, Lin HM, Trinh M, Park CH, Reich DL. Optimizing cerebral oxygenation in cardiac surgery: A randomized controlled trial examining neurocognitive and perioperative outcomes. J Thorac Cardiovasc Surg. 2020 Mar;159(3):943-953.e3. doi: 10.1016/j.jtcvs.2019.03.036. Epub 2019 Mar 29.
PubMed 31056357Parnia S, Yang J, Nguyen R, Ahn A, Zhu J, Inigo-Santiago L, Nasir A, Golder K, Ravishankar S, Bartlett P, Xu J, Pogson D, Cooke S, Walker C, Spearpoint K, Kitson D, Melody T, Chilwan M, Schoenfeld E, Richman P, Mills B, Wichtendahl N, Nolan J, Singer A, Brett S, Perkins GD, Deakin CD. Cerebral Oximetry During Cardiac Arrest: A Multicenter Study of Neurologic Outcomes and Survival. Crit Care Med. 2016 Sep;44(9):1663-74. doi: 10.1097/CCM.0000000000001723.
PubMed 27071068Heringlake M, Garbers C, Kabler JH, Anderson I, Heinze H, Schon J, Berger KU, Dibbelt L, Sievers HH, Hanke T. Preoperative cerebral oxygen saturation and clinical outcomes in cardiac surgery. Anesthesiology. 2011 Jan;114(1):58-69. doi: 10.1097/ALN.0b013e3181fef34e.
PubMed 21178669Schoen J, Meyerrose J, Paarmann H, Heringlake M, Hueppe M, Berger KU. Preoperative regional cerebral oxygen saturation is a predictor of postoperative delirium in on-pump cardiac surgery patients: a prospective observational trial. Crit Care. 2011;15(5):R218. doi: 10.1186/cc10454. Epub 2011 Sep 19.
PubMed 21929765Watzman HM, Kurth CD, Montenegro LM, Rome J, Steven JM, Nicolson SC. Arterial and venous contributions to near-infrared cerebral oximetry. Anesthesiology. 2000 Oct;93(4):947-53. doi: 10.1097/00000542-200010000-00012.
PubMed 11020744Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
PubMed 30883058Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
PubMed 27040324Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
PubMed 22922698
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Regional Oxygen Saturation During TAVI: A Prospective Comparison of Balloon-Expandable and Self-Expanding Valves
- ClinicalTrials.gov ID
- NCT07016789
- Acronym / sponsor ID
- CROS-TAVI / 7257
- Conditions
- Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic Changes
- Keywords
- TAVI, Aortic Valve Stenosis, Cerebral Oxygen Saturation, NIRS, Balloon-Expandable Valve, Self-Expanding Valve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Balloon-expandable valve (Group A) | Experimental | Device: Near-infrared spectroscopy monitoring (NIRS) INVOS 5100CParticipants in this arm will receive a balloon-expandable transcatheter heart valve (SAPIEN platform, Edwards Lifesciences). Cerebral oxygenation will be monitored during the TAVI procedure using NIRS. |
| Self-expanding intra-annular valve (Group B1) | Experimental | Device: Near-infrared spectroscopy monitoring (NIRS) INVOS 5100CParticipants in this arm will receive an intra-annular self-expanding valve (NAVITOR, Abbott). Cerebral rSO₂ will be monitored during TAVI using NIRS at predefined timepoints. |
| Self-expanding supra-annular valve (Group B2) | Experimental | Device: Near-infrared spectroscopy monitoring (NIRS) INVOS 5100CParticipants in this arm will receive a supra-annular self-expanding valve (EVOLUT, Medtronic). NIRS will be used to monitor cerebral oxygenation throughout the TAVI procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent prior to any study-specific procedures
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-infrared spectroscopy monitoring (NIRS) INVOS 5100CContinuous 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). | Device | Balloon-expandable valve (Group A), Self-expanding intra-annular valve (Group B1), Self-expanding supra-annular valve (Group B2) |
Primary outcome
Change in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI)
Time frame: 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.
3 secondary outcomes
In-hospital all-cause mortality
Time frame: From procedure to hospital discharge (up to 14 days)
In-hospital stroke incidence
Time frame: From procedure to hospital discharge (up to 14 days)
Incidence of postoperative delirium
Time frame: First 3 days after the procedure or until discharge from ICU
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 33888385VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.
- Background: PubMed 38310595Iwata S, Ozaki M. Cerebral regional oxygen saturation as a predictive parameter for preoperative heart failure and delayed hemodynamic recovery in transcutaneous aortic valve implantation: a retrospective cohort study. J Clin Monit Comput. 2024 Aug;38(4):763-772. doi: 10.1007/s10877-024-01129-2. Epub 2024 Feb 4.
- Background: PubMed 28267944Suemori T, Horton SB, Bottrell S, Skowno JJ, Davidson A. Changes in cerebral oxygen saturation and haemoglobin concentration during paediatric cardiac surgery. Anaesth Intensive Care. 2017 Mar;45(2):220-227. doi: 10.1177/0310057X1704500212.
- Background: PubMed 31056357Uysal S, Lin HM, Trinh M, Park CH, Reich DL. Optimizing cerebral oxygenation in cardiac surgery: A randomized controlled trial examining neurocognitive and perioperative outcomes. J Thorac Cardiovasc Surg. 2020 Mar;159(3):943-953.e3. doi: 10.1016/j.jtcvs.2019.03.036. Epub 2019 Mar 29.
- Background: PubMed 27071068Parnia S, Yang J, Nguyen R, Ahn A, Zhu J, Inigo-Santiago L, Nasir A, Golder K, Ravishankar S, Bartlett P, Xu J, Pogson D, Cooke S, Walker C, Spearpoint K, Kitson D, Melody T, Chilwan M, Schoenfeld E, Richman P, Mills B, Wichtendahl N, Nolan J, Singer A, Brett S, Perkins GD, Deakin CD. Cerebral Oximetry During Cardiac Arrest: A Multicenter Study of Neurologic Outcomes and Survival. Crit Care Med. 2016 Sep;44(9):1663-74. doi: 10.1097/CCM.0000000000001723.
- Background: PubMed 21178669Heringlake M, Garbers C, Kabler JH, Anderson I, Heinze H, Schon J, Berger KU, Dibbelt L, Sievers HH, Hanke T. Preoperative cerebral oxygen saturation and clinical outcomes in cardiac surgery. Anesthesiology. 2011 Jan;114(1):58-69. doi: 10.1097/ALN.0b013e3181fef34e.
- Background: PubMed 21929765Schoen J, Meyerrose J, Paarmann H, Heringlake M, Hueppe M, Berger KU. Preoperative regional cerebral oxygen saturation is a predictor of postoperative delirium in on-pump cardiac surgery patients: a prospective observational trial. Crit Care. 2011;15(5):R218. doi: 10.1186/cc10454. Epub 2011 Sep 19.
- Background: PubMed 11020744Watzman HM, Kurth CD, Montenegro LM, Rome J, Steven JM, Nicolson SC. Arterial and venous contributions to near-infrared cerebral oximetry. Anesthesiology. 2000 Oct;93(4):947-53. doi: 10.1097/00000542-200010000-00012.
- Background: PubMed 30883058Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
- Background: PubMed 27040324Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Background: PubMed 22922698Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Aortic Stenosis Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Aurigemma principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C in people with Aortic Stenosis Disease and TAVI(Transcatheter Aortic Valve Implantation), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Aurigemma, M.D. (+39 06 3015 5950, cristina.aurigemma@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral regional oxygen saturation (rSO₂) during transcatheter aortic valve implantation (TAVI) (time frame: Intraoperative, from pre-induction to end of TAVI procedure (approximately 60-90 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07016789, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.