Atrial Fibrillation (AF)HFvLTVcPPSAFENCT07402798
Anesthetic Safety of High-Frequency, Very-Low Tidal Volume Ventilation With Controlled Peak Pressure During Atrial Fibrillation Ablation
An observational study of Atrial Fibrillation (AF) and Cardiac Arrhythmias, run by Centro Medico Teknon at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Atrial Fibrillation (AF), Cardiac Arrhythmias
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2025to 4 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with paroxysmal, persistent, or permanent atrial fibrillation (AF) scheduled for radiofrequency ablation (RFA) under general anesthesia.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Severe migraine disorders.
- Trigeminal neuralgia.
- Atypical facial pain.
- Advanced hydrocephalus.
- Presence of ventriculoperitoneal shunt.
- Parkinson's disease.
- Epilepsy.
- Vertigo.
- Ménière's disease.
- Narrow-angle glaucoma.
- Prior stroke with persistent neurological deficits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Catheter ablation is an established treatment for symptomatic atrial fibrillation (AF); however, recurrence after radiofrequency ablation remains frequent, with 30-40% of patients experiencing arrhythmia recurrence after a first procedure. Effective lesion formation depends on adequate catheter-tissue contact force and stability. General anesthesia improves catheter contact compared with conscious sedation by reducing thoracic motion, yet standard mechanical ventilation does not fully eliminate respiration-induced catheter displacement.
High-frequency jet ventilation has been shown to improve catheter stability but requires specialized equipment. As an alternative, high-frequency low tidal volume ventilation (HFLTV) using conventional anesthesia ventilators has been associated with reduced thoracic motion, improved catheter stability, and shorter ablation times. Nevertheless, sustained high respiratory rates may increase intrinsic positive end-expiratory pressure (PEEP), mechanical power, intrathoracic pressure, and carbon dioxide retention, and the safety profile of these strategies has not been fully characterized.
In addition, when tidal volume approaches anatomic and circuit dead space, effective alveolar ventilation decreases and PaCO₂ may rise, while increasing respiratory rate disproportionately increases mechanical power delivered to the respiratory system. Explicit limitation of peak inspiratory pressure, a factor rarely addressed in previous studies, may reduce ventilatory energy transfer, minimize catheter motion, and mitigate adverse cardiopulmonary effects.
High-frequency very-low tidal volume ventilation with controlled peak inspiratory pressure (HFvLTV-cPP) combines ultra-low tidal volumes with strict limitation of peak inspiratory pressure (≤ 20 cmH₂O) to minimize respiration-induced catheter displacement while preserving gas exchange, limiting mechanical power, and maintaining hemodynamic stability, accepting brief and controlled permissive hypercapnia.
Since 2021, HFLTV has been routinely implemented during AF ablation at the Instituto del Corazón (ICOR), Centro Médico Teknon (Barcelona, Spain). However, no prior studies have systematically evaluated a protocol incorporating explicit peak inspiratory pressure control, nor have they comprehensively assessed anesthetic recovery and post-anesthesia safety outcomes.
This prospective, observational, within-subject crossover pilot study was designed to compare standard mechanical ventilation with HFvLTV-cPP in the same patients undergoing radiofrequency catheter ablation for AF under general anesthesia. A one-way crossover design was used for ethical reasons, as HFLTV represents the institutional standard during the ablation phase. The study focuses on paired physiological and procedural differences rather than causal inference.
Adult patients (21-85 years) with paroxysmal, persistent, or permanent AF scheduled for radiofrequency ablation were enrolled. Exclusion criteria included severe ventricular dysfunction, significant valvular disease, severe pulmonary disease with auto-PEEP, pulmonary hypertension, uncontrolled asthma, chronic metabolic acidosis, and significant neurological disorders.
All procedures were performed under total intravenous anesthesia with propofol and remifentanil, with neuromuscular blockade and invasive arterial pressure monitoring. Mechanical ventilation was delivered using a standard anesthesia workstation, with tidal volumes calculated based on adjusted body weight.
Two ventilation strategies were applied sequentially in each patient:
Standard ventilation (baseline condition): tidal volume 6 mL/kg (adjusted body weight), respiratory rate 12 breaths/min, I:E ratio 1:2, FiO₂ 0.5, PEEP 0 cmH₂O.
HFvLTV-cPP during radiofrequency ablation: respiratory rate 50 breaths/min, I:E ratio 1:1, progressive reduction of tidal volume to ≤ 3 mL/kg (adjusted body weight) while maintaining peak inspiratory pressure ≤ 20 cmH₂O.
Ventilatory transitions were performed in a standardized stepwise manner, and measurements were obtained after physiological stabilization during each phase.
The primary outcome was respiration-related ablation catheter displacement, quantitatively measured (mm) at the same left atrial site under matched contact force (10 g) during standard ventilation and HFvLTV-cPP, and qualitatively assessed by the electrophysiologist.
Secondary outcomes included within-patient comparisons of arterial PaCO₂, ventilatory mechanics, hemodynamic variables, anesthetic and vasopressor requirements, procedural parameters, and post-anesthesia recovery outcomes. Postoperative recovery was evaluated using time to eye opening, time to extubation, Aldrete score, Richmond Agitation-Sedation Scale (RASS), and the incidence of respiratory or neurological complications.
Statistical analyses were limited to paired, within-subject comparisons using appropriate parametric or non-parametric tests. The study was designed as a pilot investigation to describe physiological, procedural, and recovery profiles associated with HFvLTV-cPP compared with standard ventilation.
- Conditions
- Atrial Fibrillation (AF), Cardiac Arrhythmias
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Outcome measures were assessed intraprocedurally. Enrollement period was from May 2025 to September 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 May 2025
- Primary completion1 Sep 2025
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402798
- Sponsor's protocol ID
- ICOR-25-HFvLTV
- Other IDs
- TKN-Ethical Committee
- Acronym
- HFvLTVcPPSAFE
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07402798
- Acronym / sponsor ID
- HFvLTVcPPSAFE / ICOR-25-HFvLTV
- Conditions
- Atrial Fibrillation (AF), Cardiac Arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Catheter ablation is an established treatment for symptomatic atrial fibrillation (AF); however, recurrence after radiofrequency ablation remains frequent, with 30-40% of patients experiencing arrhythmia recurrence after a first procedure. Effective lesion formation depends on adequate catheter-tissue contact force and stability. General anesthesia improves catheter contact compared with conscious sedation by reducing thoracic motion, yet standard mechanical ventilation does not fully eliminate respiration-induced catheter displacement.
High-frequency jet ventilation has been shown to improve catheter stability but requires specialized equipment. As an alternative, high-frequency low tidal volume ventilation (HFLTV) using conventional anesthesia ventilators has been associated with reduced thoracic motion, improved catheter stability, and shorter ablation times. Nevertheless, sustained high respiratory rates may increase intrinsic positive end-expiratory pressure (PEEP), mechanical power, intrathoracic pressure, and carbon dioxide retention, and the safety profile of these strategies has not been fully characterized.
In addition, when tidal volume approaches anatomic and circuit dead space, effective alveolar ventilation decreases and PaCO₂ may rise, while increasing respiratory rate disproportionately increases mechanical power delivered to the respiratory system. Explicit limitation of peak inspiratory pressure, a factor rarely addressed in previous studies, may reduce ventilatory energy transfer, minimize catheter motion, and mitigate adverse cardiopulmonary effects.
High-frequency very-low tidal volume ventilation with controlled peak inspiratory pressure (HFvLTV-cPP) combines ultra-low tidal volumes with strict limitation of peak inspiratory pressure (≤ 20 cmH₂O) to minimize respiration-induced catheter displacement while preserving gas exchange, limiting mechanical power, and maintaining hemodynamic stability, accepting brief and controlled permissive hypercapnia.
Since 2021, HFLTV has been routinely implemented during AF ablation at the Instituto del Corazón (ICOR), Centro Médico Teknon (Barcelona, Spain). However, no prior studies have systematically evaluated a protocol incorporating explicit peak inspiratory pressure control, nor have they comprehensively assessed anesthetic recovery and post-anesthesia safety outcomes.
This prospective, observational, within-subject crossover pilot study was designed to compare standard mechanical ventilation with HFvLTV-cPP in the same patients undergoing radiofrequency catheter ablation for AF under general anesthesia. A one-way crossover design was used for ethical reasons, as HFLTV represents the institutional standard during the ablation phase. The study focuses on paired physiological and procedural differences rather than causal inference.
Adult patients (21-85 years) with paroxysmal, persistent, or permanent AF scheduled for radiofrequency ablation were enrolled. Exclusion criteria included severe ventricular dysfunction, significant valvular disease, severe pulmonary disease with auto-PEEP, pulmonary hypertension, uncontrolled asthma, chronic metabolic acidosis, and significant neurological disorders.
All procedures were performed under total intravenous anesthesia with propofol and remifentanil, with neuromuscular blockade and invasive arterial pressure monitoring. Mechanical ventilation was delivered using a standard anesthesia workstation, with tidal volumes calculated based on adjusted body weight.
Two ventilation strategies were applied sequentially in each patient:
Standard ventilation (baseline condition): tidal volume 6 mL/kg (adjusted body weight), respiratory rate 12 breaths/min, I:E ratio 1:2, FiO₂ 0.5, PEEP 0 cmH₂O.
HFvLTV-cPP during radiofrequency ablation: respiratory rate 50 breaths/min, I:E ratio 1:1, progressive reduction of tidal volume to ≤ 3 mL/kg (adjusted body weight) while maintaining peak inspiratory pressure ≤ 20 cmH₂O.
Ventilatory transitions were performed in a standardized stepwise manner, and measurements were obtained after physiological stabilization during each phase.
The primary outcome was respiration-related ablation catheter displacement, quantitatively measured (mm) at the same left atrial site under matched contact force (10 g) during standard ventilation and HFvLTV-cPP, and qualitatively assessed by the electrophysiologist.
Secondary outcomes included within-patient comparisons of arterial PaCO₂, ventilatory mechanics, hemodynamic variables, anesthetic and vasopressor requirements, procedural parameters, and post-anesthesia recovery outcomes. Postoperative recovery was evaluated using time to eye opening, time to extubation, Aldrete score, Richmond Agitation-Sedation Scale (RASS), and the incidence of respiratory or neurological complications.
Statistical analyses were limited to paired, within-subject comparisons using appropriate parametric or non-parametric tests. The study was designed as a pilot investigation to describe physiological, procedural, and recovery profiles associated with HFvLTV-cPP compared with standard ventilation.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with paroxysmal, persistent, or permanent atrial fibrillation (AF) scheduled for radiofrequency ablation (RFA) under general anesthesia.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiration related catheter stability during radiofrequency ablation.
Time frame: Outcome measures were assessed intraprocedurally. Enrollement period was from May 2025 to September 2025.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Cardiac Arrhythmias, run by Centro Medico Teknon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiration related catheter stability during radiofrequency ablation. (time frame: Outcome measures were assessed intraprocedurally. Enrollement period was from May 2025 to September 2025.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.