Radiofrequency Catheter AblationNCT06986577
Effect of Mechanical Ventilation on Cardiac RF Ablation
An observational study of Radiofrequency Catheter Ablation, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 18 years
- Conditions the study is for
- Radiofrequency Catheter Ablation
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 27 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: During the 3-month period, cardiac paediatric patients undergoing radiofrequency ablation under general anaesthesia in the catheterisation laboratory will be analysed
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Mechanical Ventilation Methods Applied During the Procedure in Pediatric Cardiac Radiofrequency Ablation Interventions: Prospective Observational Study
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
- Whether lower tidal volume high frequency mechanical ventilation effects the success of radiofrequency ablation in pediatric cardiac arryhtmia patient?
- 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.
- Lung protective mechanical ventilation with 7-9 ml/kg tidal volume,
- Low tidal volume (4 ml/kg) high frequency mechanical ventilation
- Apnea ventilation during radiofrequency ablation
- Conditions
- Radiofrequency Catheter Ablation
- Keywords
- mechanical ventilation, cardiac radiofrequency ablation, pediatric arryhtmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact force
continuously measured through the catheter
Measured: intraprosedural
Secondary outcomes (2)
Lession count
number of successful lesions
Measured: intraprosedural
Time
RF time
Measured: intraprosedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start30 Jan 2025
- Primary completion10 Feb 2026 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radiofrequency Catheter AblationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gözde Gürsoy Çirkinoğlu, Izmir City Hospital
- Investigators
- Gözde Gürsoy Çirkinoğlu, MD, Principal investigator, Izmir City Hospital, Anesthesiology and Reanimation DepartmentHalide Hande Sahinkaya, MD, Study chair, Izmir City Hospital, Anesthesiology and Reanimation DepartmentZeki Tuncel Tekgül, Prof. Dr., Study chair, University of Health Sciences, Izmir City Hospital, Anesthesiology and Reanimation DepartmentCem Karadeniz, Prof. Dr, Study chair, Izmir Katip Celebi University Medical Faculty, Pediatric Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986577
- Sponsor's protocol ID
- Mechanical Ventilation
- Status last verified
- Jan 2025
- First submitted
- 15 May 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 35333095Sivasambu 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 30573114Janson 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mechanical Ventilation Methods Applied During the Procedure in Pediatric Cardiac Radiofrequency Ablation Interventions: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06986577
- Acronym / sponsor ID
- Mechanical Ventilation
- Conditions
- Radiofrequency Catheter Ablation
- Keywords
- mechanical ventilation, cardiac radiofrequency ablation, pediatric arryhtmia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 23 May 2025 (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.
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
- Whether lower tidal volume high frequency mechanical ventilation effects the success of radiofrequency ablation in pediatric cardiac arryhtmia patient?
- The effect of mechanical ventilation strategies on the number of effective lesions, radiofrequency ablation time and arrhythmia recurrence in the first month
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.
- Lung protective mechanical ventilation with 7-9 ml/kg tidal volume,
- Low tidal volume (4 ml/kg) high frequency mechanical ventilation
- Apnea ventilation during radiofrequency ablation
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- During the 3-month period, cardiac paediatric patients undergoing radiofrequency ablation under general anaesthesia in the catheterisation laboratory will be analysed
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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
Contact force
Time frame: intraprosedural
continuously measured through the catheter
2 secondary outcomes
Lession count
Time frame: intraprosedural
Time
Time frame: intraprosedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Results publication: PubMed 35333095Osorio 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.
- Results publication: PubMed 30573114Sivasambu 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.
- Results publication: PubMed 34137629Janson 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.
- Individual participant dataSharing planned: Undecided
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The RESPLASH Study
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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.
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
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 Radiofrequency Catheter Ablation, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Contact force (time frame: intraprosedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06986577, which also lists 3 linked publications.
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 29 Jan 2026.