Heart Rate Variability After Ablation

NCT ID: NCT06276296

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-10-01

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PFA group

Patients undergoing pulsed field ablation

Holter EKG - 1 day before ablation

Intervention Type DIAGNOSTIC_TEST

24 hours Holter EKG - 1 day before ablation

Pulsed field ablation

Intervention Type PROCEDURE

Pulmonary vein isolation using pulsed field ablation

Holter EKG - 1 month after ablation

Intervention Type DIAGNOSTIC_TEST

24 hours Holter EKG 1 month after ablation

RFA group

Patients undergoing radiofrequency ablation

Holter EKG - 1 day before ablation

Intervention Type DIAGNOSTIC_TEST

24 hours Holter EKG - 1 day before ablation

Radiofrequency ablation

Intervention Type PROCEDURE

Pulmonary vein isolation using radiofrequency ablation

Holter EKG - 1 month after ablation

Intervention Type DIAGNOSTIC_TEST

24 hours Holter EKG 1 month after ablation

Interventions

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Holter EKG - 1 day before ablation

24 hours Holter EKG - 1 day before ablation

Intervention Type DIAGNOSTIC_TEST

Radiofrequency ablation

Pulmonary vein isolation using radiofrequency ablation

Intervention Type PROCEDURE

Pulsed field ablation

Pulmonary vein isolation using pulsed field ablation

Intervention Type PROCEDURE

Holter EKG - 1 month after ablation

24 hours Holter EKG 1 month after ablation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vascular surgery, University hospital Královské Vinohrady, Prague

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jana Vesela, Ph.D.

Role: CONTACT

+420267162714

Facility Contacts

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Jana Vesela, Ing.,Ph.D.

Role: primary

+420267162714

Pavel Osmancik, MD,Ph.D.

Role: backup

+420267162714

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id

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