Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF
NCT ID: NCT06828939
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2024-12-12
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
The treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System
pulsed field ablation
Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.
Interventions
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pulsed field ablation
Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.
Eligibility Criteria
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Inclusion Criteria
* Failure or intolerance of at least one AAD
* Age 18-75 years
* Patient is indicated for an ablation procedure according to society guidelines or study site practice
* Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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CardioFocus
INDUSTRY
Responsible Party
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Locations
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Na Homolce Hospital
Prague, Czech Republic, Czechia
Countries
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Central Contacts
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Other Identifiers
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25-6073
Identifier Type: -
Identifier Source: org_study_id
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