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PIVCONCT05922917

Pulsed-field Ablation in Patients With Persistent Atrial Fibrillation

StatusCompleted
PhaseNot applicable
Primary completion
Track this trial

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Record History

All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 518 participants (planned 300)
    • Primary completion date changed from estimate of Jun 30, 2026 to Jul 31, 2026
    • Study completion date changed from estimate of Nov 30, 2026 to Oct 22, 2026
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 6 to 8
    • Study description expanded, about 26 words
  2. Study sites: 1 to 3
    • Primary completion date: May 30, 2026 to Jun 30, 2026
    • Study completion date: May 30, 2026 to Nov 30, 2026
    v4
  3. Secondary endpoints: 5 to 6
    • Primary endpoint revised
    • Study description expanded, about 555 words
    • Study title shortened, about 7 words
    v2
  4. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

Atrial fibrillation recurrence
Timeframe: Whole follow-up (up to 3 years)

Secondary (8)

Atrial fibrillation recurrence on AADs
AF burden
AADs usage
Hospitalization rate
Cardioversion
Show 3 moreShow less
Complications
Atrial Fibrillation Effect on Quality of Life (AFEQT)
EuroQol Group questionnaire on quality of life

Arms and interventions

PVIActive comparator

Pulmonary vein isolation

PVI+Experimental

Pulmonary vein isolation supplemented by the additional lesions: left atrial posterior wall isolation, mitral and cavotricuspid isthmus lines

Devices: pulsed-field ablation

Sites

3 sites in 1 country