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BURST-AFNCT05572047

Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation

StatusCompleted
PhaseNot applicable
Primary completion
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Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 101 participants (planned 25)
    • Study completion date changed from estimate of Jun 2026 to Apr 24, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jan 2026 to Apr 2026
    • Site details revised at 3 of 3 sites
    v7
  3. Study sites: 2 to 3v6
  4. Primary completion date: Mar 2024 to Jan 2026
    • Study sites: 1 to 2
    • Study completion date: Sep 2024 to Jun 2026
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2022 to Oct 11, 2022
    • Site details revised
    v3
  6. Eligibility criteria revised
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Study site revised
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Serious system and procedure-related events
Timeframe: Within one week (7 days) post-procedure)
Procedural Success
Timeframe: Acute and/or up to 90 days post procedure
Chronic isolation of the pulmonary veins
Timeframe: 90 to 180 days post index procedure

Secondary (3)

Freedom from documented atrial fibrillation (AF)
Freedom from documented atrial arrhythmias (AF, AT and AFL)
Freedom from documented symptomatic recurrence of atrial arrhythmias

Arms and interventions

Coherent Sine-Burst Electroporation for AFExperimental

Patients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation (plus cavo-tricuspid isthmus ablation as necessary) Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation and posterior wall ablation (and cavo-tricuspid isthmus ablation as necessary)

Devices: Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Sites

3 sites in 2 countries

Croatia 2, Georgia 1