What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Pulsed Field Ablation (PFA), or Cryoballoon Ablation (Cryo). The registry lists allocation as randomized. The STREAMLINE-PVI trial is a prospective, single-center, randomly assigned, open-label clinical trial comparing pulsed field ablation (PFA) with cryoballoon ablation (Cryo) for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).
They plan to enroll about 94 people at Wiesbaden. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Interventions: Pulsed Field Ablation (PFA), Cryoballoon Ablation (Cryo)
Primary outcome (registry wording): Total Procedure Duration