Radiofrequency AblationNCT06791915
Effect of Mechanical Ventilation on Radiofrequency Ablation in Atrial Fibrillation
An observational study of Radiofrequency Ablation and Atrial Fibrillation, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Radiofrequency ablation (RFA) for atrial fibrillation (AF) is performed under general anesthesia. The success of the procedure depends on the safe contact of the catheter electrode with the myocardium. Movement of the catheter tip due to respiratory changes can result in inadequate lesion formation and AF recurrence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiofrequency Ablation, Atrial Fibrillation, Mechanical Ventilation
- What is being tested?
- Radiofrequency Ablation with FCV. and Radiofrequency Ablation with VCV.
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Aug 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All ASA I-II-III patients over 18 years of age with a diagnosis of atrial fibrillation who were planned to receive radiofrequency ablation treatment under general anesthesia.
Who may be able to join
- Diagnosed with atrial fibrillation
- planned to receive radiofrequency ablation treatment under general anesthesia
- all patients over 18 years of age
Who cannot join
- Patients undergoing ablation under sedation and/or local anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli City Hospital
Kocaeli
Merve Yazici Kara, +90 533 686 0156, merreset@hotmail.com
About this study
Official title: The Effect of Mechanical Ventilation on Radiofrequency Ablation in The Treatment of Atrial Fibrillation.
Radiofrequency ablation (RFA) for atrial fibrillation (AF) is performed under general anesthesia. The success of the procedure depends on the safe contact of the catheter electrode with the myocardium. Movement of the catheter tip due to respiratory changes can result in inadequate lesion formation and AF recurrence.
The success of AF ablation depends on the adequacy of energy delivered to the myocardium and the durability of pulmonary vein isolation (PVI). Poor energy delivery and tissue heating during ablation are a major cause of procedural failure in RFA. To improve the success of the PVI procedure, efforts are underway to optimize catheter stability and contact force. However, catheter force and stability are influenced by respiration-induced thoracic motion, highlighting the importance of controlled breathing for further optimization. Fluoroscopy and ablation times during electroanatomic mapping-guided AF ablations improved with controlled mechanical ventilation. General anesthesia improved catheter contact.
Low tidal volume, high respiratory rate (FCV), pressure controlled mechanical ventilation (PCV), volume controlled mechanical ventilation (VCV), pressure controlled volume assured mechanical ventilation (PRVC) can be used in investigators' hospital. The literature offers no definitive proof that one ablation procedure is superior to another.
Read the detailed description
Radiofrequency ablation for the treatment of atrial fibrillation (AF) has recently been performed under general anesthesia with patients connected to a mechanical ventilator device. There are studies showing that whether patients are connected to spontaneous or controlled ventilation directly affects the results of the ablation procedure. In the ablation procedure, safe myocardial tissue contact of the catheter electrode determines predictable lesion size distribution and ultimately procedural success. Therefore, contact force has been a reliable marker in predicting the ability to deliver an effective transmural lesion. Catheter tip movement due to respiratory changes may lead to inadequate lesion formation, potentially resulting in AF recurrence. In the existing literature, high-frequency jet ventilation (HFJV) has been reported to increase catheter stability, improve tissue contact and reduce AF recurrence due to reduced thoracic motion. An alternative strategy was used by simulating very low tidal volume ventilation with high respiratory rate with a flow similar to HFJV with standard anesthesia devices.
The incidence of atrial fibrillation recurrence following catheter ablation depends on various patient-level factors and procedural techniques. An important determinant of success in AF ablation is the adequacy of the energy delivered to the cardiac tissue and the durability of pulmonary vein isolation (PVI). Approximately 20% of patients undergoing AF ablation require re-ablation within 12 months, regardless of technique. AF recurrence following ablation occurs mainly through pulmonary vein electrical reconnection, and the rate of ≥ 1 reconnected pulmonary vein during AF reablation is >80%. Inadequate energy delivery and tissue heating due to insufficient contact or challenging anatomical locations during ablation is one of the main culprits of procedure failure in radiofrequency ablation (RFA). Therefore, efforts to improve the success of the PVI procedure include optimizing catheter stability and contact force. Thus, catheter force and stability are highly influenced by respiratory-induced thoracic movement, demonstrating the importance of controlled breathing for further ablation optimization. Fluoroscopy and ablation times during electroanatomic mapping-guided AF ablations have improved significantly with the use of controlled mechanical ventilation. To improve catheter contact, general anesthesia with controlled breathing has been used for better procedural success than conscious sedation.
To date, there are no randomized clinical trials in the literature demonstrating the superiority of one mode of ventilation over another during the ablation procedure. Low tidal volume, high respiratory rate (FCV, Flow Controlled Ventilation), pressure controlled mechanical ventilation (PCV), volume controlled mechanical ventilation (VCV), pressure controlled volume guaranteed mechanical ventilation (PRVC) can be applied with the mechanical ventilator equipment available in the anesthesiology and reanimation clinic of investigators' hospital. However, HFJV mechanical ventilator mode cannot be applied in general anesthesia patients in accordance with the facilities of investigators' hospital. In addition, there is no definite information in the literature about the superiority of any mode over the other for ablation procedure. Therefore, different mechanical ventilation modes are applied in ablation procedures in investigators' hospital according to the preferences of the practitioner. Investigators believe that there is a need for studies on the modes used in ablation procedures performed under general anesthesia.
- Being tested
- Radiofrequency Ablation with FCV., Radiofrequency Ablation with VCV.
- Keywords
- Atrial Fibrillation, Ablation, general anesthesia
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation with FCV.Procedure or surgery
Treatment of atrial fibrillation patients with radiofrequency ablation under general anesthesia with Flow Controlled Mechanical Ventilation (FCV).
Radiofrequency Ablation with VCV.Procedure or surgery
Treatment of atrial fibrillation patients with radiofrequency ablation under general anesthesia with Volume Controlled Mechanical Ventilation (VCV).
| Study group | Role | What they receive |
|---|---|---|
| Flow Controlled Mechanical Ventilation (FCV) | Controlled ventilation parameters and hemodynamic and respiratory values (systolic pressure, diastolic pressure, peak heart rate, peripheral oxygen saturation, fraction of inspired oxygen (FiO2)), and Bispectral Index monitoring (BIS) values in the patient's preferred FCV mode will be recorded. Ablation lesion parameters including mean ablation time per lesion, mean contact force, mean impedance drop, mean ablation index, and procedural characteristics including total procedure time, total ablation time, and total RF time will also be recorded. Clinical outcomes, including freedom from all atrial arrhythmias and short and long-term procedural complications, will also be recorded at routine patient follow-up. Receives: Procedure: Radiofrequency Ablation with FCV. | |
| Volume Controlled Mechanical Ventilation (VCV) | Controlled ventilation parameters and hemodynamic and respiratory values (systolic pressure, diastolic pressure, peak heart rate, peripheral oxygen saturation, fraction of inspired oxygen (FiO2)), and Bispectral Index monitoring (BIS) values in the patient's preferred VCV mode will be recorded. Ablation lesion parameters including mean ablation time per lesion, mean contact force, mean impedance drop, mean ablation index, and procedural characteristics including total procedure time, total ablation time, and total RF time will also be recorded. Clinical outcomes, including freedom from all atrial arrhythmias and short and long-term procedural complications, will also be recorded at routine patient follow-up. Receives: Procedure: Radiofrequency Ablation with VCV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiofrequency ablation procedure duration.
The effect of mechanical ventilation mode during radiofrequency ablation procedure on procedure duration.
Measured: At the end of the ablation procedure (Ablation time varies between 1 and 3 hours)
Change From Baseline Electrocardiography After Radiofrequency Ablation.
Change in baseline ECG during radiofrequency ablation procedure showing the effect of mechanical ventilation mode on procedural success.
Measured: At the end of the ablation procedure (Ablation time varies between 1 and 3 hours)
After radiofrequency ablation procedure atrial fibrillation recurrence rate.
The effect of mechanical ventilation mode during radiofrequency ablation procedure on atrial fibrillation recurrence rate.
Measured: In one month after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merve Yazici Kara, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791915
- Sponsor's protocol ID
- 2024-149
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mechanical Ventilation on Radiofrequency Ablation in The Treatment of Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT06791915
- Acronym / sponsor ID
- 2024-149
- Keywords
- Atrial Fibrillation, Ablation, general anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 24 Jan 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.
Radiofrequency ablation (RFA) for atrial fibrillation (AF) is performed under general anesthesia. The success of the procedure depends on the safe contact of the catheter electrode with the myocardium. Movement of the catheter tip due to respiratory changes can result in inadequate lesion formation and AF recurrence.
The success of AF ablation depends on the adequacy of energy delivered to the myocardium and the durability of pulmonary vein isolation (PVI). Poor energy delivery and tissue heating during ablation are a major cause of procedural failure in RFA. To improve the success of the PVI procedure, efforts are underway to optimize catheter stability and contact force. However, catheter force and stability are influenced by respiration-induced thoracic motion, highlighting the importance of controlled breathing for further optimization. Fluoroscopy and ablation times during electroanatomic mapping-guided AF ablations improved with controlled mechanical ventilation. General anesthesia improved catheter contact.
Low tidal volume, high respiratory rate (FCV), pressure controlled mechanical ventilation (PCV), volume controlled mechanical ventilation (VCV), pressure controlled volume assured mechanical ventilation (PRVC) can be used in investigators' hospital. The literature offers no definitive proof that one ablation procedure is superior to another.
Detailed description
Radiofrequency ablation for the treatment of atrial fibrillation (AF) has recently been performed under general anesthesia with patients connected to a mechanical ventilator device. There are studies showing that whether patients are connected to spontaneous or controlled ventilation directly affects the results of the ablation procedure. In the ablation procedure, safe myocardial tissue contact of the catheter electrode determines predictable lesion size distribution and ultimately procedural success. Therefore, contact force has been a reliable marker in predicting the ability to deliver an effective transmural lesion. Catheter tip movement due to respiratory changes may lead to inadequate lesion formation, potentially resulting in AF recurrence. In the existing literature, high-frequency jet ventilation (HFJV) has been reported to increase catheter stability, improve tissue contact and reduce AF recurrence due to reduced thoracic motion. An alternative strategy was used by simulating very low tidal volume ventilation with high respiratory rate with a flow similar to HFJV with standard anesthesia devices.
The incidence of atrial fibrillation recurrence following catheter ablation depends on various patient-level factors and procedural techniques. An important determinant of success in AF ablation is the adequacy of the energy delivered to the cardiac tissue and the durability of pulmonary vein isolation (PVI). Approximately 20% of patients undergoing AF ablation require re-ablation within 12 months, regardless of technique. AF recurrence following ablation occurs mainly through pulmonary vein electrical reconnection, and the rate of ≥ 1 reconnected pulmonary vein during AF reablation is >80%. Inadequate energy delivery and tissue heating due to insufficient contact or challenging anatomical locations during ablation is one of the main culprits of procedure failure in radiofrequency ablation (RFA). Therefore, efforts to improve the success of the PVI procedure include optimizing catheter stability and contact force. Thus, catheter force and stability are highly influenced by respiratory-induced thoracic movement, demonstrating the importance of controlled breathing for further ablation optimization. Fluoroscopy and ablation times during electroanatomic mapping-guided AF ablations have improved significantly with the use of controlled mechanical ventilation. To improve catheter contact, general anesthesia with controlled breathing has been used for better procedural success than conscious sedation.
To date, there are no randomized clinical trials in the literature demonstrating the superiority of one mode of ventilation over another during the ablation procedure. Low tidal volume, high respiratory rate (FCV, Flow Controlled Ventilation), pressure controlled mechanical ventilation (PCV), volume controlled mechanical ventilation (VCV), pressure controlled volume guaranteed mechanical ventilation (PRVC) can be applied with the mechanical ventilator equipment available in the anesthesiology and reanimation clinic of investigators' hospital. However, HFJV mechanical ventilator mode cannot be applied in general anesthesia patients in accordance with the facilities of investigators' hospital. In addition, there is no definite information in the literature about the superiority of any mode over the other for ablation procedure. Therefore, different mechanical ventilation modes are applied in ablation procedures in investigators' hospital according to the preferences of the practitioner. Investigators believe that there is a need for studies on the modes used in ablation procedures performed under general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow Controlled Mechanical Ventilation (FCV) | – | Procedure: Radiofrequency Ablation with FCV.Controlled ventilation parameters and hemodynamic and respiratory values (systolic pressure, diastolic pressure, peak heart rate, peripheral oxygen saturation, fraction of inspired oxygen (FiO2)), and Bispectral Index monitoring (BIS) values in the patient's preferred FCV mode will be recorded. Ablation lesion parameters including mean ablation time per lesion, mean contact force, mean impedance drop, mean ablation index, and procedural characteristics including total procedure time, total ablation time, and total RF time will also be recorded. Clinical outcomes, including freedom from all atrial arrhythmias and short and long-term procedural complications, will also be recorded at routine patient follow-up. |
| Volume Controlled Mechanical Ventilation (VCV) | – | Procedure: Radiofrequency Ablation with VCV.Controlled ventilation parameters and hemodynamic and respiratory values (systolic pressure, diastolic pressure, peak heart rate, peripheral oxygen saturation, fraction of inspired oxygen (FiO2)), and Bispectral Index monitoring (BIS) values in the patient's preferred VCV mode will be recorded. Ablation lesion parameters including mean ablation time per lesion, mean contact force, mean impedance drop, mean ablation index, and procedural characteristics including total procedure time, total ablation time, and total RF time will also be recorded. Clinical outcomes, including freedom from all atrial arrhythmias and short and long-term procedural complications, will also be recorded at routine patient follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All ASA I-II-III patients over 18 years of age with a diagnosis of atrial fibrillation who were planned to receive radiofrequency ablation treatment under general anesthesia.
Key inclusion criteria (3 listed)
- Diagnosed with atrial fibrillation
- planned to receive radiofrequency ablation treatment under general anesthesia
- all patients over 18 years of age
Key exclusion criteria (1 listed)
- Patients undergoing ablation under sedation and/or local anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency Ablation with FCV.Treatment of atrial fibrillation patients with radiofrequency ablation under general anesthesia with Flow Controlled Mechanical Ventilation (FCV). | Procedure or surgery | Flow Controlled Mechanical Ventilation (FCV) |
| Radiofrequency Ablation with VCV.Treatment of atrial fibrillation patients with radiofrequency ablation under general anesthesia with Volume Controlled Mechanical Ventilation (VCV). | Procedure or surgery | Volume Controlled Mechanical Ventilation (VCV) |
Primary outcome
Radiofrequency ablation procedure duration.
Time frame: At the end of the ablation procedure (Ablation time varies between 1 and 3 hours)
The effect of mechanical ventilation mode during radiofrequency ablation procedure on procedure duration.
Change From Baseline Electrocardiography After Radiofrequency Ablation.
Time frame: At the end of the ablation procedure (Ablation time varies between 1 and 3 hours)
Change in baseline ECG during radiofrequency ablation procedure showing the effect of mechanical ventilation mode on procedural success.
After radiofrequency ablation procedure atrial fibrillation recurrence rate.
Time frame: In one month after procedure.
The effect of mechanical ventilation mode during radiofrequency ablation procedure on atrial fibrillation recurrence rate.
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 24 Jan 2025.
Related trials for Radiofrequency Ablation
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruitingObservational study
Observation Study on the Efficacy and Safety of Hepatic Artery Embolization Combined With Radiofrequency Ablation for Hepatic Hemangioma: The Impact of Different Treatment Intervals
Hepatic Hemangioma
Not yet recruitingObservational study
Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study
Ampullary Neoplasm, Ampullary Adenoma
RecruitingObservational study
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Esophageal Neoplasm, Esophageal Polyp
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.
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 Ablation and Atrial Fibrillation, run by Kocaeli 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 1 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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?
Contact Merve Yazici Kara (+90 533 686 0156, merreset@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiofrequency ablation procedure duration. (time frame: At the end of the ablation procedure (Ablation time varies between 1 and 3 hours)). The study lists 3 primary outcomes in all. 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 24 Jan 2025.