Ischaemic Cerebral InfarctionNCT06786988
Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation
An observational study of Ischaemic Cerebral Infarction, run by Charles University, Czech Republic.
Trial summary
A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Cerebral Infarction
- What is being tested?
- MRI
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Dec 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 with a common clinical indication for AF ablation.
Who may be able to join
- AF with an indication for ablation
Who cannot join
- MRI contraindication
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system).
Read the detailed description
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.
- Conditions
- Ischaemic Cerebral Infarction
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Patients undegoing AF ablation | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischaemic lesion
ischemic lesion on MRI
Measured: 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)
Secondary outcomes (2)
Neurocognitive evaluation
Change in the MoCA test result
Measured: one day before the procedure (the first MoCA test) and up to 1 year after the procedure (the second MoCA test)
NIHSS score
Measured: 24-36 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischaemic Cerebral InfarctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Hozman, MD, PhD, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786988
- Sponsor's protocol ID
- CNS_MRI_PFA
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laskov V, Hozman M, Malikova H, Lauer D, Kremenova K, Herman D, Hassouna S, Hornof J, Filipcova V, Vesela J, Waldauf P, Michalovova M, Karch J, Poviser L, Osmancik P. Cerebrovascular Ischemic Lesions After Pulsed Field Ablation for Atrial Fibrillation Using Variable-Loop Ablation Catheter. JACC Clin Electrophysiol. 2026 Apr;12(4):814-823. doi: 10.1016/j.jacep.2025.12.018. Epub 2026 Jan 22.
PubMed 41575412
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06786988
- Acronym / sponsor ID
- CNS_MRI_PFA
- Conditions
- Ischaemic Cerebral Infarction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Jan 2025 (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.
A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undegoing AF ablation | – | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a common clinical indication for AF ablation.
Key inclusion criteria (1 listed)
- AF with an indication for ablation
Key exclusion criteria (1 listed)
- MRI contraindication
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 |
|---|---|---|
| MRIbrain MRI scan: (1) one day before the procedure, (2) 24-36 hours after the procedure and (3) up to 1 year after the procedure | Diagnostic test | Patients undegoing AF ablation |
Primary outcome
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
2 secondary outcomes
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)
NIHSS score
Time frame: 24-36 hours after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 41575412Laskov V, Hozman M, Malikova H, Lauer D, Kremenova K, Herman D, Hassouna S, Hornof J, Filipcova V, Vesela J, Waldauf P, Michalovova M, Karch J, Poviser L, Osmancik P. Cerebrovascular Ischemic Lesions After Pulsed Field Ablation for Atrial Fibrillation Using Variable-Loop Ablation Catheter. JACC Clin Electrophysiol. 2026 Apr;12(4):814-823. doi: 10.1016/j.jacep.2025.12.018. Epub 2026 Jan 22.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischaemic Cerebral Infarction, 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 1 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 22 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 Viktor Laskov, MD (+420267 161 111, viktor.laskov@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 NCT06786988, 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 22 Jan 2025.