Clinical trial NCT06276296: Heart Rate Variability After Ablation
Official title: Evaluation of Heart Rate Variability in Patients After Ablation Using Pulsed Field and Radiofrequency
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Heart rate variability
Pulsed field ablation
Radiofrequency ablation
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Vascular surgery, University hospital Královské Vinohrady, Prague
First posted: 2024-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with paroxysmal symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Mean RR interval (ms)
timeFrame: 1 month
measure: SDNN (ms)
timeFrame: 1 month
measure: RMSSD (ms)
timeFrame: 1 month
measure: pNN50 (%)
timeFrame: 1 month
measure: peak frequency (Hz)
timeFrame: 1 month
measure: power (ms2)
timeFrame: 1 month
measure: LF/HF ratio
timeFrame: 1 month
measure: SD1 (ms)
timeFrame: 1 month
measure: SD2 (ms)
timeFrame: 1 month
measure: SD2/SD1
timeFrame: 1 month
measure: ApEn
timeFrame: 1 month
measure: Correlation dimension
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Study officials:
References: