Clinical Trials Logo

Clinical Trial Summary

Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. The use of HFNO could be justified in this context and could improve the results and safety of these procedures. The use of HFNO during sedation for TAVR could increase oxygen content and minimise hypercapnia, which occurs frequently. This may have 2 potential benefits: one in terms of facilitating the patient's tolerance to anaesthetic sedation; and the other to optimise oxygen delivery to organs such as the brain, kidneys, and myocardium. Primary aim The number of oxygen desaturation episodes. An oxygen desaturation episode is defined as any episode of Sp02 <93% for more than 10 seconds. Method A single-center prospective randomised controlled clinical trial with 132 individuals comparing the use of High Flow Nasal oxygen (intervention group) with the conventional standard of care oxygenation with nasal cannula standard oxygenation (control group) of patients undergoing sedation for transfemoral TAVR. The randomisation process will be carried out with a 1:1 assignment, using the RedCap Clínic tool for this purpose. Both groups will be treated at the same centre and by the same interventional cardiology and anaesthesia team. Sedation regime will be based on Target controlled infusion (TCI) with propofol and remifentanil. Local anaesthesia will be infiltrated by interventional cardiologist prior obtaining femoral vascular access. 50 L/min with 0.6% FiO2 will be administered through a high-flow nasal cannula in the intervention group. In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05958537
Study type Interventional
Source Hospital Clinic of Barcelona
Contact Marc Trilla, MsC
Phone +34 93 227 54 00
Email mtrilla@clinic.cat
Status Recruiting
Phase N/A
Start date November 1, 2023
Completion date September 30, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Completed NCT03332745 - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting NCT06008080 - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting NCT06055751 - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting NCT04815785 - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis N/A
Terminated NCT02202434 - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement N/A
Recruiting NCT03029026 - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting NCT02903420 - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) N/A
Completed NCT02629328 - CardioCel Tri-leaflet Repair Study N/A
Completed NCT02306226 - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Completed NCT01676727 - ADVANCE Direct Aortic Study
Withdrawn NCT01648309 - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation N/A
Completed NCT01422044 - Risk Prediction in Aortic Stenosis N/A
Withdrawn NCT00774657 - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography N/A
Terminated NCT00535899 - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) N/A
Terminated NCT05070130 - OpSens PRIME CLASS
Completed NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Completed NCT04157920 - Impact of Predilatation Between Self-expanding Valves N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting NCT05893082 - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR N/A