NCT06276296

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 23, 2024

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

February 6, 2024

Last Update Submit

February 22, 2024

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationHeart rate variabilityPulsed field ablationRadiofrequency ablation

Outcome Measures

Primary Outcomes (12)

  • Mean RR interval (ms)

    Time domain parameter

    1 month

  • SDNN (ms)

    Standard deviation of RR intervals - time domain parameter

    1 month

  • RMSSD (ms)

    root mean square of successive differences - time domain parameter

    1 month

  • pNN50 (%)

    the number of successive intervals differing more than 50 ms or the corresponding relative amount - time domain parameter

    1 month

  • peak frequency (Hz)

    The frequency-domain measures extracted from a spectrum estimate for each frequency band (very low, low and high)

    1 month

  • power (ms2)

    A parameter obtained from the estimation of the frequency spectrum

    1 month

  • LF/HF ratio

    Ratio between low frequency and high frequency band powers

    1 month

  • SD1 (ms)

    In Poincaré plot, the standard deviation perpendicular to the line-of-identity

    1 month

  • SD2 (ms)

    In Poincaré plot, the standard deviation along the line-of-identity

    1 month

  • SD2/SD1

    Ratio between SD2 and SD1

    1 month

  • ApEn

    Approximate entropy

    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

    1 month

Study Arms (2)

PFA group

Patients undergoing pulsed field ablation

Diagnostic Test: Holter EKG - 1 day before ablationProcedure: Pulsed field ablationDiagnostic Test: Holter EKG - 1 month after ablation

RFA group

Patients undergoing radiofrequency ablation

Diagnostic Test: Holter EKG - 1 day before ablationProcedure: Radiofrequency ablationDiagnostic Test: Holter EKG - 1 month after ablation

Interventions

Holter EKG - 1 day before ablationDIAGNOSTIC_TEST

24 hours Holter EKG - 1 day before ablation

PFA groupRFA group
Radiofrequency ablationPROCEDURE

Pulmonary vein isolation using radiofrequency ablation

RFA group
Pulsed field ablationPROCEDURE

Pulmonary vein isolation using pulsed field ablation

PFA group
Holter EKG - 1 month after ablationDIAGNOSTIC_TEST

24 hours Holter EKG 1 month after ablation

PFA groupRFA group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with paroxysmal symptomatic atrial fibrillation fulfilling standard criteria for catheter ablation

You may qualify if:

  • paroxysmal atrial fibrillation
  • indication for catheter ablation due to atrial fibrillation
  • willingness to participate

You may not qualify if:

  • atrial fibrillation throughout Holter ECG recording
  • significant valve disease
  • left ventricular dysfunction, EF less than 35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Prague, 10034, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electrocardiography, AmbulatoryRadiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElectrocardiographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMonitoring, AmbulatoryMonitoring, PhysiologicRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Jana Vesela, Ph.D.

CONTACT

+420267162714janca.zd@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 23, 2024

Study Start

March 1, 2023

Primary Completion

August 31, 2024

Study Completion

October 1, 2024

Last Updated

February 23, 2024

Record last verified: 2023-10

Locations

CZ(1)