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

NCT07016789 | Not Yet Recruiting

• 1 other identifier: 7257
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative, from pre-induction to end of TAVI procedure (approximately 60-90 minutes)

Secondary Outcomes (3)

• In-hospital all-cause mortality

  From procedure to hospital discharge (up to 14 days)

• In-hospital stroke incidence

  From procedure to hospital discharge (up to 14 days)

• Incidence of postoperative delirium

  First 3 days after the procedure or until discharge from ICU

Other Outcomes (1)

• Exploratory comparison of cerebral oxygen saturation across all three valve types

  Intraoperative, from pre-induction to end of TAVI procedure (approximately 60-90 minutes)

Study Arms (3)

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.

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.

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.

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

Interventions

Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C DEVICE

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).

Balloon-expandable valve (Group A); Self-expanding intra-annular valve (Group B1); Self-expanding supra-annular valve (Group B2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

Related Publications (12)

• 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.

  PMID: 33888385 BACKGROUND

• Iwata 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.

  PMID: 38310595 BACKGROUND

• Suemori 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.

  PMID: 28267944 BACKGROUND

• Uysal 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.

  PMID: 31056357 BACKGROUND

• Parnia 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.

  PMID: 27071068 BACKGROUND

• Heringlake 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.

  PMID: 21178669 BACKGROUND

• Schoen 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.

  PMID: 21929765 BACKGROUND

• Watzman 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.

  PMID: 11020744 BACKGROUND

• Mack 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.

  PMID: 30883058 BACKGROUND

• Leon 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.

  PMID: 27040324 BACKGROUND

• Leon 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.

  PMID: 20961243 BACKGROUND

• Vahanian 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.

  PMID: 22922698 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Cristina Aurigemma

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Aurigemma, M.D.

CONTACT

+39 06 3015 5950; cristina.aurigemma@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 12, 2025
• Study Start: June 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)