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Heart Rate Variability After Ablation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06276296
Enrollment
60
Registered
2024-02-23
Start date
2023-03-01
Completion date
2024-10-01
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Heart rate variability, Pulsed field ablation, Radiofrequency 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.

Interventions

DIAGNOSTIC_TESTHolter EKG - 1 day before ablation

24 hours Holter EKG - 1 day before ablation

PROCEDURERadiofrequency ablation

Pulmonary vein isolation using radiofrequency ablation

PROCEDUREPulsed field ablation

Pulmonary vein isolation using pulsed field ablation

DIAGNOSTIC_TESTHolter EKG - 1 month after ablation

24 hours Holter EKG 1 month after ablation

Sponsors

Vascular surgery, University hospital Královské Vinohrady, Prague
CollaboratorOTHER
Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frameDescription
Mean RR interval (ms)1 monthTime domain parameter
SDNN (ms)1 monthStandard deviation of RR intervals - time domain parameter
RMSSD (ms)1 monthroot mean square of successive differences - time domain parameter
pNN50 (%)1 monththe number of successive intervals differing more than 50 ms or the corresponding relative amount - time domain parameter
peak frequency (Hz)1 monthThe frequency-domain measures extracted from a spectrum estimate for each frequency band (very low, low and high)
power (ms2)1 monthA parameter obtained from the estimation of the frequency spectrum
LF/HF ratio1 monthRatio between low frequency and high frequency band powers
SD1 (ms)1 monthIn Poincaré plot, the standard deviation perpendicular to the line-of-identity
SD2 (ms)1 monthIn Poincaré plot, the standard deviation along the line-of-identity
SD2/SD11 monthRatio between SD2 and SD1
ApEn1 monthApproximate entropy
Correlation dimension1 monthThe correlation dimension is expected to give information on the minimum number of dynamic variables needed to model the underlying system

Countries

Czechia

Contacts

Primary ContactJana Vesela, Ph.D.
janca.zd@gmail.com+420267162714

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026