Effect of Mechanical Ventilation on Radiofrequency Ablation in Atrial Fibrillation

NCT06791915 | Recruiting

• 1 other identifier: 2024-149
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiofrequency Ablation; Atrial Fibrillation; Mechanical Ventilation

Keywords

Atrial Fibrillation; Ablation; general anesthesia

Outcome Measures

Primary Outcomes (3)

• Radiofrequency ablation procedure duration.

  The effect of mechanical ventilation mode during radiofrequency ablation procedure on procedure duration.

  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.

  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.

  In one month after procedure.

Study Arms (2)

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.

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.

Procedure: Radiofrequency Ablation with VCV.

Interventions

Radiofrequency Ablation with FCV. PROCEDURE

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

Flow Controlled Mechanical Ventilation (FCV)

Radiofrequency Ablation with VCV. PROCEDURE

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

Volume Controlled Mechanical Ventilation (VCV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Patients undergoing ablation under sedation and/or local anesthesia

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation; Famciclovir

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Merve Yazici Kara

CONTACT

+90 533 686 0156; merreset@hotmail.com

Nurseda Dundar

CONTACT

+90 530 510 2245; d.nurseda@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 24, 2025
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

TU (1)