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Pulsed-Field-Ablation to Treat Atrial fiBRillation With a novEl multimodalIty Generator

Study acronym: PFA-Breisgau
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 3, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Lead sponsor: Universitätsklinikum Hamburg-Eppendorf to University Hospital Freiburg
    • Study title revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In this first-in-human clinical trial a novel generator (INTELLAPULSE), designed and built by Stockert, which supports highly flexible PFA protocols as well as RF interventions will be used. For 12 months and follow-up for 12 months, after a 3-months blanking period 50 consecutive paroxysmal AF patients, eligible for catheter ablation, will be enrolled.
Trial Details
NCT Number NCT06156644
Lead Sponsor University Hospital Freiburg
Conditions
(from sponsor)		 Atrial Fibrillation
Related terms Atrial Fibrillation
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov