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Atrial Fibrillation (AF)FARA BlockNCT06803238

Procedural Mitral Isthmus Block Durability After Pulsed-Field Ablation in Patients with Non-Paroxysmal Atrial Fibrillation

An observational study of Atrial Fibrillation (AF), run by Charles University, Czech Republic.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Mitral isthmus is one of the targets for the catheter ablation of non-paroxysmal atrial fibrillation (AF), in which pulmonary veins isolation alone is not deemed sufficient. Typically, lateral mitral isthmus ablation line is performed from the mitral annulus to the ostium of the left inferior pulmonary vein or to the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
How many people
40 participants
Where
No sites listed yet
Study dates
Jan 2025to Apr 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients referred for catheter ablation of non paroxysmal AF by referring cardiologists and from arrythmology clinic

Who may be able to join

  • adult patients with symptomatic non-paroxysmal atrial fibrillation indicated for catheter ablation according to the current guidelines

Who cannot join

  • Contraindication to catheter ablation according to the current guidelines
  • previous left atrial ablation
  • left ventricular dysfunction with LV EF < 30%
  • Patients at high risk of prolonged analgosedation, e.g. history of severe COPD (stage 3 or 4), obstructive sleep apnea on treatment

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Pavel Osmancik, prof. MD., Ph.D. contact

+420267161111

pavel.osmancik@gmail.com

About this study

Mitral isthmus is one of the targets for the catheter ablation of non-paroxysmal atrial fibrillation (AF), in which pulmonary veins isolation alone is not deemed sufficient. Typically, lateral mitral isthmus ablation line is performed from the mitral annulus to the ostium of the left inferior pulmonary vein or to the posterior base of the left atrial appendage. When conduction block across the mitral isthmus is achieved, the standard practice using radiofrequency energy is to wait 20 minutes to verify durability of the conduction block.

Currently, there is an increase in procedures performed using pulsed-field energy (PF). The procedure is in most centers terminated immediately after the energy is delivered, and, unlike radiofrequency energy procedures, there is no waiting period to see if the conduction through the ablation lines returns. However return of conduction across the mitral isthmus has been described during reablation procedures performed for clinical recurrence of arrhythmia (perimitral flutter or atrial fibrillation).

Read more

The presented study is a follow-up of previous work, which included 30 patients with non-paroxysmal AF, who underwent PF ablation including mitral isthmus ablation as part of the procedure. Ablation of the mitral isthmus was performed by repeated series of 9 PF energy applications. After each series a waiting period of 20 minutes followed. In case of recurrence of conduction, another series of 9 PF applications was delivered followed by a new waiting period. In the cases of reconduction after the 3rd series, one last series of PF applications was performed, where the number of applications was left at the discretion of the operator, where the total number of applications delivered to the mitral isthmus could not exceed 50. We found that although conduction block on the mitral isthmus was achieved in 90 % of patients after all series, it was only in 33,3 % of patients after the first series. Repeated waiting and multiple ablation series prolonged the procedure unnecessarily. On the other hand, a very high number of pulsed-field energy applications applied initially could be associated with a risk of hemolysis. So far, the number of PF applications up to 80-100 were demonstrated to be safe.

This present study aims to determine whether increasing the number of applications in the first series delivered to the mitral isthmus will be associated with faster and durable achievement of conduction block across the mitral isthmus.

A total of 40 patients with symptomatic non-paroxysmal AF, indicated for catheter ablation according to current guidelines, will be included. Patients with previous left atrial ablation, presenting left ventricular dysfunction with LV EF < 30%, as well as patients at high risk of prolonged analgosedation (i.g. history of severe COPD, treated OSA) will be excluded. The procedure will be performed according to the standards of our center, i.e. pulmonary veins isolation, left atrial posterior wall ablation and mitral isthmus ablation will be performed. All procedures will be performed under analgosedation or general anesthesia controlled by an anesthesiologist. All ablations will be made using PF energy (system FARAPULSE, Boston sci., USA) and under control of intracardiac echocardiography. In contrast to previous work, a total of 20 applications of PF energy will be administered to the mitral isthmus in the first series of ablation. A waiting period of 20 minutes will follow, during which the conduction block across the mitral isthmus will be verified by assessment of the activation sequence on the decapolar catheter in the coronary sinus when pacing from the base of the left atrial appendage and by assessment of the activation of the left atrial appendage when pacing from the distal coronary sinus (or by differential pacing in case of uncertainity). If there is no recurrence of conduction across the mitral isthmus within 20 min, the procedure will be terminated. If recurrence does occur, a second series of 20 PF energy applications will be administered and another 20-minute waiting period will be initiated. In the case of reconduction after the 2nd series, one last optional ablation series will be delivered at the discretion of the operator. For safety reasons, the total waiting time will be 40 minutes and the total number of PF energy applications to the mitral isthmus will be limited to 50 (in the third series, only 10 applications can be delivered). After the procedure, the catheters and sheaths will be withdrawn and the site of puncture fixed with Z suture. All patients will receive 1000 mL of saline postproceduraly and will be endouredged to drink sufficient amount of fluids on the day after the procedure. Renal function (BUN, creatinine) will be assessed on the following day after the procedure.

Keywords
atrial fibrillation, catheter ablation, pulsed-field ablation, mitral isthmus
Medical subject headings
Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mitral isthmus block durability after 1 series of PF applications

    Acute mitral isthmus conduction block sustained for a waiting period of 20 minutes after 1 series of 20 PF applications

    Measured: 20 minutes after last PF application

Secondary outcomes (1)
  1. Overall mitral isthmus block durability

    Overall acute mitral isthmus conduction block achieved by the protocol-defined ablation (of up to 3 ablation series of up to 50 PF applications) and sustained for a waiting period of 20 minutes

    Measured: 20 minutes after last PF application of last ablation series

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study startJan 2025 (estimated)
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803238
Sponsor's protocol ID
FARA Block
Acronym
FARA Block
Status last verified
Jan 2025
First submitted
27 Jan 2025
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No

Publications

  • Hornof J, Hozman M, Herman D, Romanenko O, Hassouna S, Vesela J, Filipcova V, Poviser L, Karch J, Hozmanova J, Znojilova L, Molova A, Penkava V, Osmancik P. Acute Efficacy of Pulsed-Field Ablation of the Mitral Isthmus Using a Pentaspline Catheter and Two Different Ablation Settings. J Cardiovasc Electrophysiol. 2026 Feb;37(2):390-399. doi: 10.1111/jce.70236. Epub 2025 Dec 27.

    PubMed 41456097

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF), run by Charles University, Czech Republic.

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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pavel Osmancik, prof. MD., Ph.D. (+420267161111, pavel.osmancik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mitral isthmus block durability after 1 series of PF applications (time frame: 20 minutes after last PF application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803238, which also lists 1 linked publication.

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 31 Jan 2025.

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