An interventional study of Pulsed Field Ablation (PFA) and Cryoballoon Ablation (Cryo) in Atrial Fibrillation (AF), sponsored by St. Josefs-Hospital Wiesbaden GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by St. Josefs-Hospital Wiesbaden GmbH · Not applicable, Interventional, and Treatment
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 94 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →St. Josefs-Hospital Wiesbaden GmbH is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this arm will undergo pulmonary vein isolation using pulsed field ablation (PFA) within a standardized Lean Six Sigma-optimized workflow.
Procedure: Pulsed Field Ablation (PFA)
Patients randomized to this arm will undergo pulmonary vein isolation using cryoballoon ablation (Cryo) within a standardized Lean Six Sigma-optimized workflow.
Procedure: Cryoballoon Ablation (Cryo)
Pulmonary vein isolation using the Medtronic PulseSelect system under conscious sedation.
Pulmonary vein isolation using the Medtronic Arctic Front Advance system under conscious sedation.
Total Procedure Duration
otal procedure duration, defined as the time from first vascular puncture to application of the venous compression bandage, measured in minutes.
Time frame: During the ablation procedure
Time to Post-Anesthetic Recovery
Time from application of the venous compression bandage to achievement of a Post-Anesthetic Recovery Score of ≥9 points, measured in minutes.
Time frame: Immediately after the ablation procedure until achievement of a score ≥9
Post-Anesthetic Recovery Score at 1 Hour
Post-Anesthetic Recovery Score assessed one hour after application of the venous compression bandage (range 0-10, higher scores indicating better recovery).
Time frame: 1 hour after the ablation procedure
Time to Same-Day Discharge Readiness
Time from application of the venous compression bandage to achievement of a Same-Day Readiness Score (SDRS) ≥8 points, indicating readiness for safe mobilization and discharge.
Time frame: Starting 4 hours after the ablation procedure until discharge readiness
Atrial Fibrillation/Atrial Tachycardia Burden
Atrial fibrillation and atrial tachycardia burden assessed by rhythm monitoring during the 12-month follow-up period.
Time frame: 12 months after ablation
Recurrence of Atrial Arrhythmias
Proportion of patients experiencing documented atrial arrhythmia recurrence (AF, atrial flutter, or atrial tachycardia) lasting ≥30 seconds, including the 8-week blanking period.
Time frame: Within 12 months after ablation
All-Cause Mortality
Proportion of patients experiencing death from any cause during follow-up.
Time frame: Within 12 months after ablation
Stroke or Transient Ischemic Attack
Proportion of patients experiencing fatal or nonfatal stroke or transient ischemic attack (TIA).
Time frame: Within 12 months after ablation
Cardiovascular Hospitalization
Proportion of patients requiring hospitalization for cardiovascular causes during follow-up.
Time frame: Within 12 months after ablation
Procedure-Related Complications
Proportion of patients experiencing procedure-related complications, including death, stroke/TIA, major bleeding (BARC ≥2), major vascular complications, pericardial effusion or tamponade, systemic embolism, phrenic nerve injury, atrio-esophageal fistula, hemolysis, nosocomial infections requiring hospitalization, or coronary spasm.
Time frame: Within 30 days after ablation
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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St. Josefs-Hospital Wiesbaden GmbH