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Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Sponsor: St. Josefs-Hospital Wiesbaden GmbH
Summary
The STREAMLINE-PVI trial is a prospective, single-center, randomized, open-label clinical trial comparing pulsed field ablation (PFA) with cryoballoon ablation (Cryo) for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). A total of 94 patients undergoing first-time PVI will be randomized 1:1 to either PFA or Cryo within standardized Lean Six Sigma (LSS)-optimized procedural workflows. The primary objective is to evaluate whether PFA reduces total procedure duration by at least 20% compared with Cryo without compromising safety or efficacy. Secondary outcomes include post-procedural recovery, readiness for same-day discharge, atrial arrhythmia recurrence, AF burden, and procedural complications during a 12-month follow-up period.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2026-10-26
Completion Date
2027-11-30
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Pulsed Field Ablation (PFA)
Pulmonary vein isolation using the Medtronic PulseSelect system under conscious sedation.
Cryoballoon Ablation (Cryo)
Pulmonary vein isolation using the Medtronic Arctic Front Advance system under conscious sedation.
Locations (1)
St. Josefs-Hospital Wiesbaden
Wiesbaden, Germany