Clinical trial NCT06791915: Effect of Mechanical Ventilation on Radiofrequency Ablation in Atrial Fibrillation
Official title: The Effect of Mechanical Ventilation on Radiofrequency Ablation in The Treatment of Atrial Fibrillation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiofrequency Ablation
Atrial Fibrillation
Mechanical Ventilation
Keywords: Atrial Fibrillation
Ablation
general anesthesia
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with atrial fibrillation
* planned to receive radiofrequency ablation treatment under general anesthesia
* all patients over 18 years of age

Exclusion Criteria:

- Patients undergoing ablation under sedation and/or local anesthesia

Primary outcomes:
measure: Radiofrequency ablation procedure duration.
timeFrame: At the end of the ablation procedure (Ablation time varies between 1 and 3 hours)
measure: Change From Baseline Electrocardiography After Radiofrequency Ablation.
timeFrame: At the end of the ablation procedure (Ablation time varies between 1 and 3 hours)
measure: After radiofrequency ablation procedure atrial fibrillation recurrence rate.
timeFrame: In one month after procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
Study officials:
References: