High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II

NCT07059728 | Recruiting

• 1 other identifier: HCB/2025/0514
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy. Patients selected for this procedure often have a profile associated with multiple comorbidities which predispose them to certain complications. TAVI procedures were initially performed under general anesthesia. However, due to improved procedure times and anesthetic techniques, sedation has become the current trend to preform them. When sedation for these procedures requires deep planes, hypoxia is more likely to occur due to respiratory depression, apnea, or airway obstruction. This is even more common in TAVR patients population, as obesity, sleep apnea, elevated ASA classification, advanced age, and combined cardiorespiratory disease are highly prevalent. For all these reasons, TAVR constitutes a risky procedure, presenting a profile of patients undergoing this procedure that can also be considered high risk. The provision of supplemental oxygen through nasal cannulae or face masks can prevent the development of hypoxia. Unfortunately, non-humidified nasal oxygen cannot exceed 2-5 L/min without causing damage to the nasal mucosa, and the percentage of oxygen delivered through variable-flow face masks is unpredictable. On the other hand, high-flow nasal oxygen therapy (HFNO) can provide humidified gas flow rates of up to 70 L/min through specially adapted nasal cannulae and reliably deliver oxygen concentrations between 21% and 100%. The use of HFNC could be justified in this context and could improve the outcomes and safety of these procedures, increasing oxygen content and minimizing hypercapnia. The study's hypothesis is HFNO will prevent hypoxemia and control hypercapnia during sedation for transcatheter aortic valve implantation (TAVI) better than conventional oxygen theraphy. Clinical and serological biomarkers of tissue injury will decrease with the use of HFNO. Clinical complications will decrease with the use of HFNO. The study population would be all patients \>18 years of age undergoing TAVI procedure and who agree to participate in the study in 8 centers in Barcelona.

Conditions

Aortic Stenosis Treated With TAVI; Sedation; Aged; Hemodynamics

Keywords

Aortic Stenosis; TAVR; Sedation

Outcome Measures

Primary Outcomes (2)

• Postoperative complications

  Reduction in complications at 30 days post-procedure). Classic composite variable that includes: 30-day post-procedure mortality, need for hospital readmission due to acute heart failure, incidence of stroke, and incidence of acute kidney injury.

  From enrollment to 30 days after intervention

• Win ratio

  Win ratio analysis for outcomes: 30-day post-procedure mortality, need for hospital readmission for acute heart failure, incidence of acute stroke, incidence of acute kidney injury, and quality of life (measured by the Kansas Questionnaire)

  From enrollment to 30 days after the intervention ends

Secondary Outcomes (12)

• Number of Desaturation episodes

  From enrollment until end of TAVR procedure

• Desaturation incidence

  From enrollment until the end of TAVR procedure

• PaO2

  At enrollment and at 45 minutes after enrollment

• PaCO2

  At enrollment and at 45 minutes after enrollment.

• Neuronal Specific Enolase

  At enrollment and at 8 hours after enrollment.

Study Arms (2)

HFNO group

EXPERIMENTAL

Patients recieving high flow nasal oxygenation

Device: Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)

Control group

ACTIVE COMPARATOR

Patients recieving standard of care oxygen theraphy (5L/min via nasal cannulae)

Device: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min

Interventions

Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2) DEVICE

Intervention group: Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2)

HFNO group

Oxygen therapy during sedation delivered via nasal cannulae at 5L/min DEVICE

Control group: Oxygen therapy during sedation delivered via nasal cannulae at 5L/min

Control group

Eligibility Criteria

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

You may qualify if:

• Transfemoral TAVR elective procedure
• Age \>18 years

You may not qualify if:

• Patients under 18 years of age
• Refusal to participate
• Known allergy to propofol or remifentanil.
• Non-femoral surgical access.
• Presence of a basal skull fracture or pneumothorax
• Procedure duration \< 45 minutes
• Previously planned general anaesthesia approach due to patient's condition or procedural technical reasons
• Need to convert to general anesthesia for non-respiratory complications within 45 minutes.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 11, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-06

Locations

ES (1)