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NCT Number: NCT06478342

Left Atrial Function After Pulsed Field Ablation of Atrial Fibrillation

Introduction: Pulsed field ablation (PFA) has emerged in routine clinical practice as a new promising technology in catheter-based treatment of atrial fibrillation (AF). The ease of PFA technology enables more extensive ablation in shorter time. On one hand, extensive ablation is advocated to decrease the AF recurrence in persistent patients, on the other hand it is an important predictor of developing left atrial stiff syndrome with a reported incidence rate of 3.7 - 8.2 % in persistent patients during the era of radiofrequency ablation.

Goals of the study: The main hypothesis is that the LA function (strain) will tend to decline after extensive PFA. It will be assessed using transthoracic echocardiography (TTE) and magnetic resonance (MRI).

Secondary endpoint analysis will include the evaluation of the distribution of late gadolinium enhancement (LGE) after ablation compared to baseline scans, evaluation of heart failure biomarkers after ablation, and description of the rate of AF recurrence.

Methods: This project is a prospective, nonrandomised, two-centre (University Hospital Kralovske Vinohrady and University Hospital Motol) observational study including 50 non-paroxysmal AF patients with indication for catheter ablation. Before the ablation, all patients will undergo LGE MRI and TTE (after cardioversion if AF present). The ablation procedure will be performed using pulsed field technology and will include pulmonary vein isolation, posterior wall ablation and mitral isthmus ablation. Patients will be followed for 6 months. 3 months after the ablation, LGE MRI will be performed. TTE examinations will be carried out on the day after the ablation, at 3 and at 6 months. Heart failure biomarkers (N-terminal proatrial natriuretic peptide, fibroblast growth factor 23, and galectin 3) levels will be analysed at baseline, and 3 and 6 months after the procedure. ECG Holter monitoring will be performed at 3- and 6-months visits.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-paroxysmal AF with an indication for catheter ablation
  • Age above 18
  • Signed informed consent

Exclusion criteria

  • Contraindication to MRI
  • BMI > 35 kg/m2
  • Contraindication to amiodarone
  • Left atrial size > 60 mm
  • History of any LA ablation
  • Significant valvular disease (mitral regurgitation ¾ or greater, moderate or severe aortic stenosis)
  • Severe pulmonary hypertension
  • Pregnancy

Treatment and study plan

Ablation

Procedure

Pulsed field ablation, MRI and TEE examinations (LA strain)

Primary outcomes

  1. Changes in LA function (strain) by MRI (baseline vs. 3m values)

    Time frame: Baseline MRI to 3 months after procedure

    LA strain (baseline vs. 3 months)

  2. Changes in LA function (strain) by TTE (baseline vs. 3m values)

    Time frame: Procedure to 3 months

    LA strain (baseline vs. 3 months)

Secondary outcomes

  1. Changes in LA fibrosis distribution (LGE MRI) (baseline vs. 3 m values)

    Time frame: Baseline MRI to 3 months after procedure

    LGE evaluation (baseline vs. 3 months MRI)

  2. Changes in ANP, FGF 23, GAL 3 levels (baseline vs. 3 m values)

    Time frame: baseline vs. 3 m values

    laboratory analysis

  3. AF freedom

    Time frame: Procedure to 6 months visit

    defined as an absence of AF/atrial tachycardia lasting > 30 s during follow-up including Holter monitoring

  4. Changes in strain function on TTE over time

    Time frame: baseline TTE to 6 months control

    comparison of strain values obtained at all 4 time points

Study contacts

Contact information is provided by the study sponsor or research team.

Marek Hozman, MD

CONTACT

[email protected]

+420267161111

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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