Pulsed Field vs Cryoballoon for Pulmonary Vein Isolation in Atrial Fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

STREAMLINE-PVI is a prospective, single-center, randomized study that compares two ablation methods for atrial fibrillation. Ninety-four adults undergoing first-time PVI are randomized 1:1 to pulsed field ablation or cryoballoon ablation within Lean Six Sigma–optimized workflows. The trial's primary goal is to see if PFA reduces total procedure time by at least 20% without sacrificing safety or efficacy. Secondary outcomes include recovery time, readiness for same-day discharge, atrial arrhythmia recurrence and AF burden, and procedural complications over a 12-month follow-up. The study is conducted at St. Josefs-Hospital Wiesbaden with the sponsor overseeing the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Previous catheter ablation for atrial fibrillation
* Reversible cause of atrial fibrillation (e.g., thyrotoxicosis, alcohol ingestion)
* Coexisting non-pulmonary vein-dependent atrial tachycardia
* Heart failure with reduced ejection fraction (LVEF ≤40%)
* Indication for pacemaker or implantable cardioverter-defibrillator (ICD) implantation
* Severe mitral stenosis or regurgitation, or previous mitral valve repair or replacement
* Known intracardiac thrombus formation despite continuous oral anticoagulation for more than 4 weeks
* Incessant ventricular tachycardia
* Surgical coronary revascularization within the previous 30 days
* Myocardial infarction within the previous 30 days
* Ongoing triple antithrombotic therapy following percutaneous coronary intervention (PCI)
* 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

Where it's running

• St. Josefs-Hospital Wiesbaden
  Wiesbaden, Germany Recruiting

Study contacts

• Study coordinator: Joachim R Ehrlich, Prof. Dr.
• Email: jehrlich@joho.de
• Phone: +49 611 1771200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.