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Active, not recruitingNCT06986577Updated Jan 29, 2026

Effect of Mechanical Ventilation on Cardiac RF Ablation

An observational study in Radiofrequency Catheter Ablation, sponsored by Izmir City Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 0 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Izmir City Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
0 Months to 18 Years
Sex
All
01

Study summary

The aim of this study is to describe the results of cardiac radiofrequency ablation under general anesthesia.

to evaluate mechanical ventilation methods in pediatric patients. The main questions it aims to answer are

  1. Whether lower tidal volume high frequency mechanical ventilation effects the success of radiofrequency ablation in pediatric cardiac arryhtmia patient?
  2. The effect of mechanical ventilation strategies on the number of effective lesions, radiofrequency ablation time and arrhythmia recurrence in the first month
Read the detailed description

Radiofrequency ablation (RF) is an effective method for the threatment of cardiac arrhythmias in pediatric patients. General anaesthesia and mechanical ventilation is the most common anesthesia management for pediatric arrhythmia patients. During the prosedure, thoracic excursion results in displacement of the catheter and disrupts the catheter stability which is crucial for quality of contact force (CF), sufficient ablation and safety. To minimize the thoracic excursion, high frequency low tidal volume ventilation and apnea ventilation may be needed during radiofrequency ablation. According to investigators knowledge there are studies about ventilatory strategies in adult patients who underwent cardiac radiofrequency ablation. However, there are no studies corcerning pediatric patients. In this study investigators aimed to investigate best ventilatory strategy for minimize thoracic excursion in pediatric patients with general anaesthesia. In this study investigators are going to observe 3 different ventilation strategies on radiofrequency ablation.

  1. Lung protective mechanical ventilation with 7-9 ml/kg tidal volume,
  2. Low tidal volume (4 ml/kg) high frequency mechanical ventilation
  3. Apnea ventilation during radiofrequency ablation
02

Conditions studied

  • Radiofrequency Catheter Ablation

Keywords

  • mechanical ventilation
  • cardiac radiofrequency ablation
  • pediatric arryhtmia
03

In context

Lead sponsor

Izmir City Hospital is the lead sponsor of 23 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

During the 3-month period, cardiac paediatric patients undergoing radiofrequency ablation under general anaesthesia in the catheterisation laboratory will be analysed

Inclusion criteria

  • Between 0-18 years
  • Paediatric surgery under general anaesthesia at Izmir City Hospital in the last 3 months since the date undergoing cardiac radiofrequency ablation procedure
  • Procedures were performed with catheters with contract force measurement feature patients with

Exclusion criteria

Exclusion Criteria:

  • Patients with maintenance other than inhalation anaesthesia
  • Patients whose anaesthesia method is changed during the procedure
  • Patients with airway complications
  • Development of haemodynamic instability during the procedure
  • Patient with a history of previous cardiac surgery
  • Presence of additional cardiac disease, advanced connective tissue disease, connective tissue disease, mitochondrial muscle disease
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 1) Lung protective mechanical ventilation

    Mechanical ventilation with 7-9 ml tidal volume during RF

  • 2) Low tidal volume high frequency ventilation

    Mechanical ventilation with 4 ml tidal volume with high frequency during RF

  • 3) Apnea ventilation

    Apne ventilastion during RF

06

What researchers measure

Primary outcomes

  1. Contact force

    continuously measured through the catheter

    Time frame: intraprosedural

Secondary outcomes

  1. Lession count

    number of successful lesions

    Time frame: intraprosedural

  2. Time

    RF time

    Time frame: intraprosedural

07

Study locations

1 site
  • İzmir City Hospital
    Izmir, Turkey (Türkiye)
08

References and documents

Publications

  • Osorio J, Varley A, Kreidieh O, Godfrey B, Schrappe G, Rajendra A, Silverstein J, Romero J, Rodriguez D, Morales G, Zei P. High-Frequency, Low-Tidal-Volume Mechanical Ventilation Safely Improves Catheter Stability and Procedural Efficiency During Radiofrequency Ablation of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010722. doi: 10.1161/CIRCEP.121.010722. Epub 2022 Mar 25. No abstract available. PubMed 35333095 ↗
  • Sivasambu B, Hakim JB, Barodka V, Chrispin J, Berger RD, Ashikaga H, Ciuffo L, Tao S, Calkins H, Marine JE, Trayanova N, Spragg DD. Initiation of a High-Frequency Jet Ventilation Strategy for Catheter Ablation for Atrial Fibrillation: Safety and Outcomes Data. JACC Clin Electrophysiol. 2018 Dec;4(12):1519-1525. doi: 10.1016/j.jacep.2018.08.016. Epub 2018 Nov 1. PubMed 30573114 ↗
  • Janson CM, Shah MJ, Kennedy KF, Iyer VR, Sweeten TL, Glatz AC, Steven JM, O'Byrne ML. Comparison of Outcomes of Pediatric Catheter Ablation by Anesthesia Strategy: A Report From the NCDR IMPACT Registry. Circ Arrhythm Electrophysiol. 2021 Jul;14(7):e009849. doi: 10.1161/CIRCEP.121.009849. Epub 2021 Jun 17. PubMed 34137629 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06986577
Lead sponsor
Izmir City Hospital
Responsible party
Gözde Gürsoy Çirkinoğlu (MD, Izmir City Hospital) — Principal investigator
First posted
May 23, 2025
Start date
Jan 30, 2025
Primary completion
Feb 10, 2026 (estimated)
Completion
Feb 27, 2026 (estimated)
Last update
Jan 29, 2026

Study contacts

Gözde Gürsoy Çirkinoğlu, MD
principal investigator · Izmir City Hospital, Anesthesiology and Reanimation Department
Halide Hande Sahinkaya, MD
study chair · Izmir City Hospital, Anesthesiology and Reanimation Department
Zeki Tuncel Tekgül, Prof. Dr.
study chair · University of Health Sciences, Izmir City Hospital, Anesthesiology and Reanimation Department
Cem Karadeniz, Prof. Dr
study chair · Izmir Katip Celebi University Medical Faculty, Pediatric Cardiology Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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