Anesthetic Safety of High-Frequency, Very-Low Tidal Volume Ventilation With Controlled Peak Pressure During Atrial Fibrillation Ablation

NCT07402798 | Completed

• 2 other identifiers: ICOR-25-HFvLTVTKN-Ethical Committee
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, observational, within-subject crossover pilot study evaluates the impact of a high-frequency, very-low tidal volume ventilation strategy with controlled peak inspiratory pressure (HFvLTV-cPP) on respiration-induced ablation catheter displacement during atrial fibrillation (AF) radiofrequency ablation performed under general anesthesia. In the same patients, standard mechanical ventilation is compared with HFvLTV-cPP during the ablation phase to quantify catheter stability under matched contact force conditions. Secondary objectives include assessment of arterial carbon dioxide levels, ventilatory mechanics, hemodynamic parameters, anesthetic requirements, and post-anesthesia recovery outcomes. The study aims to determine whether limiting peak inspiratory pressure while using high respiratory rates and ultra-low tidal volumes improves catheter stability while maintaining acceptable gas exchange, cardiopulmonary safety, and postoperative recovery profiles.

Conditions

Atrial Fibrillation (AF); Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (1)

• Respiration related catheter stability during radiofrequency ablation.

  Respiration-related catheter stability was assessed quantitatively as catheter displacement (millimeters) during radiofrequency ablation. Catheter displacement was measured under standard mechanical ventilation and after 15 minutes of high-frequency, very low-tidal-volume ventilation with continuous positive pressure (HFvLTV-cPP).

  Outcome measures were assessed intraprocedurally. Enrollement period was from May 2025 to September 2025.

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with paroxysmal, persistent, or permanent atrial fibrillation (AF) scheduled for radiofrequency ablation (RFA) under general anesthesia.

You may qualify if:

• Adults aged 21-85 years.
• Diagnosed with paroxysmal, persistent, or permanent atrial fibrillation (AF).
• Scheduled for radiofrequency ablation (RFA) under general anesthesia.
• Patients undergoing repeat ablation procedures included for evaluation of ventilatory, anesthetic, and post-anesthesia recovery parameters.
• Patients undergoing repeat ablation procedures excluded from analyses related to procedural efficacy outcomes.

You may not qualify if:

• Left or right ventricular dysfunction.
• Severe tricuspid regurgitation.
• Severe pulmonary hypertension.
• Severe chronic obstructive pulmonary disease (COPD) with evidence of auto-positive end-expiratory pressure.
• Uncontrolled severe asthma.
• Chronic metabolic acidosis with associated hyperkalemia.
• Severe migraine disorders.
• Trigeminal neuralgia.
• Atypical facial pain.
• Advanced hydrocephalus.
• Presence of ventriculoperitoneal shunt.
• Parkinson's disease.
• Epilepsy.
• Vertigo.
• Ménière's disease.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (1)

Teknon Medical Center

Barcelona, Barcelona, Spain, 08022, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carlos Ramírez-Paesano,MD,PhD

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 11, 2026
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 4, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

ES (1)