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NCT Number: NCT06786988

Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation

A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

An observational study evaluating the incidence of ischaemic lesions on brain MRI performed after ablation of atrial fibrillation using the Varipulse catheter.

  • A baseline MRI scan will be carried out one day before the procedure.
  • A post-procedure MRI scan will be performed 24-36 hours after the procedure.
  • A follow-up MRI will be performed within 1 year after the ablation.

Paroxysmal and non-paroxysmal AF patients will be included. Regarding the extent of ablation lesions, pulmonary vein isolation (PVI) will be performed in paroxysmal AF, whereas PVI + left atrial posterior wall ablation will be performed in non-paroxysmal patients. All procedures will be performed under intracardiac echocardiography guidance.

The patients will undergo a neurocognitive evaluation:

  • One day before the procedure: Montreal Cognitive Assessment (The MoCA Test)
  • 24-36 hours after the procedure: The National Institutes of Health Stroke Scale (NIHSS)
  • Up to 1 year after the procedure the MoCA test.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AF with an indication for ablation

Exclusion criteria

  • MRI contraindication

Treatment and study plan

MRI

Diagnostic Test

brain MRI scan: (1) one day before the procedure, (2) 24-36 hours after the procedure and (3) up to 1 year after the procedure

Primary outcomes

  1. ischaemic lesion

    Time frame: one day before the procedure (the first MRI scan), 24-36 hour sfter the procedure (the second scan) and up to 1 year after the procedure (the third scan)

    ischemic lesion on MRI

Secondary outcomes

  1. Neurocognitive evaluation

    Time frame: one day before the procedure (the first MoCA test) and up to 1 year after the procedure (the second MoCA test)

    Change in the MoCA test result

  2. NIHSS score

    Time frame: 24-36 hours after the procedure

Study contacts

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

Viktor Laskov, MD

CONTACT

[email protected]

+420267 161 111

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

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.