Heart Rate Variability After Ablation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Holter EKG - 1 day before ablation; Procedure: Pulsed field ablation; Diagnostic test: Holter EKG - 1 month after ablation; Procedure: 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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Jana Vesela, Ph.D.; Phone Number: +420267162714; Email: janca.zd@gmail.com

Study Locations

• Czechia
  • Prague, Czechia, 10034
    • Recruiting
    • Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
    • Contact: Jana Vesela, Ing.,Ph.D.; Phone Number: +420267162714; Email: janca.zd@gmail.com
    • Contact: Pavel Osmancik, MD,Ph.D.; Phone Number: +420267162714; Email: pavel.osmancik@fmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with paroxysmal symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PFA group; Patients undergoing pulsed field ablation	Diagnostic test: Holter EKG - 1 day before ablation; 24 hours Holter EKG - 1 day before 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
RFA group; Patients undergoing radiofrequency ablation	Diagnostic test: Holter EKG - 1 day before ablation; 24 hours Holter EKG - 1 day before ablation; Diagnostic test: Holter EKG - 1 month after ablation; 24 hours Holter EKG 1 month after ablation; Procedure: Radiofrequency ablation; Pulmonary vein isolation using radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Vascular surgery, University hospital Královské Vinohrady, Prague

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Heart rate variability; Radiofrequency ablation; Pulsed field ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 0001 (Cancer Research Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No