Heart Rate Variability After Ablation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276296
• Other study ID #: 0001
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Charles University, Czech Republic
• Contact: Jana Vesela, Ph.D.
• Phone: +420267162714
• Email: janca.zd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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
• 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

Locations

Country	Name	City	State
Czechia	Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Vascular surgery, University hospital Královské Vinohrady, Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean RR interval (ms)	Time domain parameter	1 month
Primary	SDNN (ms)	Standard deviation of RR intervals - time domain parameter	1 month
Primary	RMSSD (ms)	root mean square of successive differences - time domain parameter	1 month
Primary	pNN50 (%)	the number of successive intervals differing more than 50 ms or the corresponding relative amount - time domain parameter	1 month
Primary	peak frequency (Hz)	The frequency-domain measures extracted from a spectrum estimate for each frequency band (very low, low and high)	1 month
Primary	power (ms2)	A parameter obtained from the estimation of the frequency spectrum	1 month
Primary	LF/HF ratio	Ratio between low frequency and high frequency band powers	1 month
Primary	SD1 (ms)	In Poincaré plot, the standard deviation perpendicular to the line-of-identity	1 month
Primary	SD2 (ms)	In Poincaré plot, the standard deviation along the line-of-identity	1 month
Primary	SD2/SD1	Ratio between SD2 and SD1	1 month
Primary	ApEn	Approximate entropy	1 month
Primary	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