Clinical Trial

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

Study acronym: HFvLTVcPPSAFE
Completed
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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.
Trial Details
NCT Number NCT07402798
Lead Sponsor Centro Medico Teknon
Conditions Atrial Fibrillation (AF), Cardiac Arrhythmias
Enrollment 52 participants
Start Date 2025-05-01
Primary Completion 2025-09-01 (estimated)
Study Completion 2026-02-04 (estimated)
Updated on ClinicalTrials.gov 2026-02-11