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ARIADNE RCTNCT06747091

ARIADNE Clinical Trial

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Minor Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 32 words
    • Site details revised at 3 of 3 sites
    • Study description expanded, about 3 words
  2. Notable Primary completion date: Aug 1, 2025 to Dec 1, 2026
    • Study completion date: Jan 1, 2026 to Mar 1, 2027
    • Site contacts updated at 1 of 3 sites
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Dec 20, 2024 to Mar 18, 2025
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percent of subjects free from primary effectiveness failure
Timeframe: 12 Months

Arms and interventions

PVI using PFA energyActive comparator

Pulmonary vein isolation using PFA energy

PVI and posterior wall isolation using PFA energyActive comparator

Pulmonary vein isolation and posterior wall isolation using PFA energy

PVI and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.Active comparator

Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy.

Procedures: Catheter Ablation

Sites

3 sites in 1 country