Heart Rate Variability After Ablation

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06276296
• Lead Sponsor: Charles University, Czech Republic

Brief 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.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2023-10
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-22
• Last Update Submitted: 2024-02-22
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-08-31
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• paroxysmal atrial fibrillation
• indication for catheter ablation due to atrial fibrillation
• willingness to participate

Exclusion Criteria

• atrial fibrillation throughout Holter ECG recording
• significant valve disease
• left ventricular dysfunction, EF less than 35%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SDNN (ms)	1 month	Standard deviation of RR intervals - time domain parameter
SD2/SD1	1 month	Ratio between SD2 and SD1
ApEn	1 month	Approximate entropy
pNN50 (%)	1 month	the number of successive intervals differing more than 50 ms or the corresponding relative amount - time domain parameter
LF/HF ratio	1 month	Ratio between low frequency and high frequency band powers
SD2 (ms)	1 month	In Poincaré plot, the standard deviation along the line-of-identity
power (ms2)	1 month	A parameter obtained from the estimation of the frequency spectrum
SD1 (ms)	1 month	In Poincaré plot, the standard deviation perpendicular to the line-of-identity
Correlation dimension	1 month	The correlation dimension is expected to give information on the minimum number of dynamic variables needed to model the underlying system
RMSSD (ms)	1 month	root mean square of successive differences - time domain parameter
peak frequency (Hz)	1 month	The frequency-domain measures extracted from a spectrum estimate for each frequency band (very low, low and high)
Mean RR interval (ms)	1 month	Time domain parameter

Trial Locations

Locations (1)

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady; 🇨🇿 Prague, Czechia