NCT07402798Completed
Anesthetic Safety of High-Frequency, Very-Low Tidal Volume Ventilation With Controlled Peak Pressure During Atrial Fibrillation Ablation
Respiration-induced Ablation Catheter Displacement and Anesthetic Safety of High-Frequency, Very-Low Tidal Volume Ventilation With Controlled Peak Pressure During Atrial Fibrillation Ablation: An Observational Crossover Pilot Study
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 52 (actual)
- First submitted
- 26 Jan 2026
- Start date
- 1 May 2025
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Centro Medico Teknon
- Diseases
- Atrial fibrillation
- NCT number
- NCT07402798
What you commit to
- Study type: Observational
- Participants enrolled: 52
- From 1 May 2025 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior stroke with persistent neurological deficits.
Other illness
- Severe pulmonary hypertension.
- Severe chronic obstructive pulmonary disease (COPD) with evidence of auto-positive end-expiratory pressure.
- Severe migraine disorders.
- Parkinson's disease.
- Epilepsy.
- Ménière's disease.
Other
- Left or right ventricular dysfunction.
- Severe tricuspid regurgitation.
- Uncontrolled severe asthma.
- Chronic metabolic acidosis with associated hyperkalemia.
- Trigeminal neuralgia.
- Atypical facial pain.
- Advanced hydrocephalus.
- Presence of ventriculoperitoneal shunt.
- Vertigo.
- Narrow-angle glaucoma.
Who the study is looking for
- 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.
Age in the registry: 21 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Teknon Medical center Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.