Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276296
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-06
Brief Title:
Heart Rate Variability After Ablation
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Evaluation of Heart Rate Variability in Patients After Ablation Using Pulsed Field and Radiofrequency
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None