NCT06786988

Brief 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).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

January 10, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 10, 2025

Last Update Submit

January 21, 2025

Conditions

Ischaemic Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

  • ischaemic lesion

    ischemic lesion on MRI

    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

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

  • NIHSS score

    24-36 hours after the procedure

Study Arms (1)

Patients undegoing AF ablation

Diagnostic Test: MRI

Interventions

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

Patients undegoing AF ablation

Eligibility Criteria

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

Patients with a common clinical indication for AF ablation.

You may qualify if:

  • AF with an indication for ablation

You may not qualify if:

  • MRI contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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 Jan 5:S2405-500X(25)01032-1. doi: 10.1016/j.jacep.2025.12.018. Online ahead of print.

    PMID: 41575412DERIVED

Central Study Contacts

Viktor Laskov, MD

CONTACT

+420267 161 111viktor.laskov@fnkv.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional electrophysiologist

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 22, 2025

Study Start

February 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01