Clinical Trial

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

Study acronym: PFA-Breisgau
Not Yet Recruiting
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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.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-12-04.
Trial Details
NCT Number NCT06156644
Lead Sponsor University Hospital Freiburg
Conditions Atrial Fibrillation
Enrollment 50 participants
Start Date 2025-07-01
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2024-01-03