Atrial FibrillationNCT06276296
Heart Rate Variability After Ablation
An observational study of Atrial Fibrillation, run by Charles University, Czech Republic at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Holter EKG - 1 day before ablation, Radiofrequency ablation and Pulsed field ablation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with paroxysmal symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation
Who may be able to join
- paroxysmal atrial fibrillation
- indication for catheter ablation due to atrial fibrillation
- willingness to participate
Who cannot join
- atrial fibrillation throughout Holter ECG recording
- significant valve disease
- left ventricular dysfunction, EF less than 35%
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, 10034
Jana Vesela, Ing.,Ph.D., +420267162714, janca.zd@gmail.com
Pavel Osmancik, MD,Ph.D., +420267162714, pavel.osmancik@fmail.com
About this study
Official title: Evaluation of Heart Rate Variability in Patients After Ablation Using Pulsed Field and Radiofrequency
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Holter EKG - 1 day before ablation, Radiofrequency ablation, Pulsed field ablation, Holter EKG - 1 month after ablation
- Keywords
- Atrial fibrillation, Heart rate variability, Pulsed field ablation, Radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter EKG - 1 day before ablationDiagnostic test
24 hours Holter EKG - 1 day before ablation
Radiofrequency ablationProcedure or surgery
Pulmonary vein isolation using radiofrequency ablation
Pulsed field ablationProcedure or surgery
Pulmonary vein isolation using pulsed field ablation
Holter EKG - 1 month after ablationDiagnostic test
24 hours Holter EKG 1 month after ablation
| Study group | Role | What they receive |
|---|---|---|
| PFA group | Patients undergoing pulsed field ablation Receives: Diagnostic Test: Holter EKG - 1 day before ablation; Procedure: Pulsed field ablation; Diagnostic Test: Holter EKG - 1 month after ablation | |
| RFA group | Patients undergoing radiofrequency ablation Receives: Diagnostic Test: Holter EKG - 1 day before ablation; Procedure: Radiofrequency ablation; Diagnostic Test: Holter EKG - 1 month after ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean RR interval (ms)
Time domain parameter
Measured: 1 month
SDNN (ms)
Standard deviation of RR intervals - time domain parameter
Measured: 1 month
RMSSD (ms)
root mean square of successive differences - time domain parameter
Measured: 1 month
pNN50 (%)
the number of successive intervals differing more than 50 ms or the corresponding relative amount - time domain parameter
Measured: 1 month
peak frequency (Hz)
The frequency-domain measures extracted from a spectrum estimate for each frequency band (very low, low and high)
Measured: 1 month
power (ms2)
A parameter obtained from the estimation of the frequency spectrum
Measured: 1 month
LF/HF ratio
Ratio between low frequency and high frequency band powers
Measured: 1 month
SD1 (ms)
In Poincaré plot, the standard deviation perpendicular to the line-of-identity
Measured: 1 month
SD2 (ms)
In Poincaré plot, the standard deviation along the line-of-identity
Measured: 1 month
SD2/SD1
Ratio between SD2 and SD1
Measured: 1 month
ApEn
Approximate entropy
Measured: 1 month
Correlation dimension
The correlation dimension is expected to give information on the minimum number of dynamic variables needed to model the underlying system
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Mar 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Vascular surgery, University hospital Královské Vinohrady, Prague
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276296
- Sponsor's protocol ID
- 0001
- Status last verified
- Oct 2023
- First submitted
- 6 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heart Rate Variability in Patients After Ablation Using Pulsed Field and Radiofrequency
- ClinicalTrials.gov ID
- NCT06276296
- Acronym / sponsor ID
- 0001
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Heart rate variability, Pulsed field ablation, Radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Vascular surgery, University hospital Královské Vinohrady, Prague
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFA group | – | Diagnostic Test: Holter EKG - 1 day before ablation, Procedure: Pulsed field ablation, Diagnostic Test: Holter EKG - 1 month after ablationPatients undergoing pulsed field ablation |
| RFA group | – | Diagnostic Test: Holter EKG - 1 day before ablation, Procedure: Radiofrequency ablation, Diagnostic Test: Holter EKG - 1 month after ablationPatients undergoing radiofrequency ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with paroxysmal symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation
Key inclusion criteria (3 listed)
- paroxysmal atrial fibrillation
- indication for catheter ablation due to atrial fibrillation
- willingness to participate
Key exclusion criteria (3 listed)
- atrial fibrillation throughout Holter ECG recording
- significant valve disease
- left ventricular dysfunction, EF less than 35%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter EKG - 1 day before ablation24 hours Holter EKG - 1 day before ablation | Diagnostic test | PFA group, RFA group |
| Radiofrequency ablationPulmonary vein isolation using radiofrequency ablation | Procedure or surgery | RFA group |
| Pulsed field ablationPulmonary vein isolation using pulsed field ablation | Procedure or surgery | PFA group |
| Holter EKG - 1 month after ablation24 hours Holter EKG 1 month after ablation | Diagnostic test | PFA group, RFA group |
Primary outcome
Mean RR interval (ms)
Time frame: 1 month
Time domain parameter
SDNN (ms)
Time frame: 1 month
Standard deviation of RR intervals - time domain parameter
RMSSD (ms)
Time frame: 1 month
root mean square of successive differences - time domain parameter
pNN50 (%)
Time frame: 1 month
the number of successive intervals differing more than 50 ms or the corresponding relative amount - time domain parameter
peak frequency (Hz)
Time frame: 1 month
The frequency-domain measures extracted from a spectrum estimate for each frequency band (very low, low and high)
power (ms2)
Time frame: 1 month
A parameter obtained from the estimation of the frequency spectrum
LF/HF ratio
Time frame: 1 month
Ratio between low frequency and high frequency band powers
SD1 (ms)
Time frame: 1 month
In Poincaré plot, the standard deviation perpendicular to the line-of-identity
SD2 (ms)
Time frame: 1 month
In Poincaré plot, the standard deviation along the line-of-identity
SD2/SD1
Time frame: 1 month
Ratio between SD2 and SD1
ApEn
Time frame: 1 month
Approximate entropy
Correlation dimension
Time frame: 1 month
The correlation dimension is expected to give information on the minimum number of dynamic variables needed to model the underlying system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jana Vesela, Ph.D. (+420267162714, janca.zd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean RR interval (ms) (time frame: 1 month). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024; AzTrials last refreshed its copy on 3 Nov 2026.