NCT06276296

Heart Rate Variability After Ablation

Evaluation of Heart Rate Variability in Patients After Ablation Using Pulsed Field and Radiofrequency

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Pulsed-field catheter ablation is a promising new treatment method for patients with atrial fibrillation. The mechanism of cell damage here is different from that of classic catheter ablation, in which the ganglion plexuses around the pulmonary veins are also damaged and thus changes in the autonomic nervous system occur. The aim of the work is to find out, using heart rate variability, whether the autonomic system is less affected during pulsed field ablation than in classic radiofrequency ablation.

Detailed description

Catheter ablation for pulmonary vein isolation (PVI) is the most effective treatment method for atrial fibrillation (AF). For a long time, radiofrequency energy (RFA) was dominantly used for ablation, which leads to tissue heating and thus thermal damage. The methodology of pulsed-field ablation, or irreversible electroporation, has been completely newly developed. This form of energy does not lead to thermal tissue damage (as is the case with radiofrequency energy), but with the help of high-intensity nanopulses of electrical energy, the ion channels of cardiomyocytes are permanently opened, the concentration gradient of ions is canceled and thus their irreversible destruction. In addition to the electrical isolation of the pulmonary vein, standard radiofrequency isolation of the pulmonary veins leads to the ablation of collateral ganglion plexuses and thus to the influence of the autonomic nervous system. This is very positive, an imbalance between sympathetic and parasympathetic innervating the left atrium is considered a risk factor for AF induction, and its damage with standard RFA is considered part of the RFA ablation effect. Available studies suggest that PFA probably induces significantly weaker and less permanent suppression of cardiac autonomic regulation compared to RF energy used for PVI. Measuring heart rate variability is a simple non-invasive method. A regular ECG Holter recorder can be used for the measurement. Patients will be fitted with a 24-hour Holter ECG on admission to determine the original heart rate variability. Catheter ablation will take place the next day. Patients will be treated using one of two methods of pulmonary vein isolation - RFA or PFA. One month after the catheterization procedure, a 24-hour Holter ECG will be used again to detect changes in HRV compared to preoperative values.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Holter EKG - 1 day before ablation	24 hours Holter EKG - 1 day before ablation
PROCEDURE	Radiofrequency ablation	Pulmonary vein isolation using radiofrequency ablation
PROCEDURE	Pulsed field ablation	Pulmonary vein isolation using pulsed field ablation
DIAGNOSTIC_TEST	Holter EKG - 1 month after ablation	24 hours Holter EKG 1 month after ablation

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-08-31
• Completion: 2024-10-01
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

1 site across 1 country: Czechia