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Effect of Mechanical Ventilation on Radiofrequency Ablation in Atrial Fibrillation

The Effect of Mechanical Ventilation on Radiofrequency Ablation in The Treatment of Atrial Fibrillation.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06791915
Enrollment
50
Registered
2025-01-24
Start date
2025-01-01
Completion date
2025-08-01
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Mechanical Ventilation, Radiofrequency Ablation

Keywords

Atrial Fibrillation, Ablation, 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.

Interventions

PROCEDURERadiofrequency Ablation with FCV.

Treatment of atrial fibrillation patients with radiofrequency ablation under general anesthesia with Flow Controlled Mechanical Ventilation (FCV).

PROCEDURERadiofrequency Ablation with VCV.

Treatment of atrial fibrillation patients with radiofrequency ablation under general anesthesia with Volume Controlled Mechanical Ventilation (VCV).

Sponsors

Kocaeli City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Radiofrequency ablation procedure duration.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.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.In one month after procedure.The effect of mechanical ventilation mode during radiofrequency ablation procedure on atrial fibrillation recurrence rate.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMerve Yazici Kara
merreset@hotmail.com+90 533 686 0156
Backup ContactNurseda Dundar
d.nurseda@hotmail.com+90 530 510 2245

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026