NCT07910370Recruiting
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 26 Oct 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Diseases
- Atrial fibrillation
- NCT number
- NCT07910370
What you commit to
- Study type: Interventional
- Planned participants: 94
- From 26 Oct 2026 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Lab values
- Heart failure with reduced ejection fraction (LVEF ≤40%)
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Josefs Hospital Wiesbaden Coordinator of this site? Confirm its status | Wiesbaden | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.