Comparing two heart ablation methods for atrial fibrillation
Compares pulsed field ablation with cryoballoon ablation in adults having a first atrial fibrillation procedure.
Plain-language title generated from the registry record
Registry title: Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Key facts
- Where
- Wiesbaden, GermanySee the site
Where in Germany
- St. Josefs Hospital WiesbadenWiesbaden, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Josefs-Hospital Wiesbaden GmbH
- Trial code
- NCT07910370
- Record updated
- 2 November 2026
- Original description
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).Read full original descriptionShow less
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
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.
Inclusion: Age ≥18 years; Willingness to participate and ability to provide informed consent; Atrial fibrillation diagnosed within the past 2 years; Scheduled for first-time pulmonary vein isolation (PVI).
Exclusion: Previous catheter ablation for atrial fibrillation; Severe mitral stenosis or regurgitation, or previous mitral valve repair or replacement; Surgical coronary revascularization within the previous 30 days; Myocardial infarction within the previous 30 days; Ongoing triple antithrombotic therapy following percutaneous coronary intervention (PCI); Heart failure with reduced ejection fraction (LVEF ≤40%); Reversible cause of atrial fibrillation (e.g., thyrotoxicosis, alcohol ingestion); Coexisting non-pulmonary vein-dependent atrial tachycardia; Indication for pacemaker or implantable cardioverter-defibrillator (ICD) implantation; Known intracardiac thrombus formation despite continuous oral anticoagulation for more than 4 weeks; Incessant ventricular tachycardia; Contraindication to contrast media; Contraindication to oral anticoagulation; Body mass index (BMI) >35 kg/m²; Inability to provide written informed consent; Life expectancy <12 months.