Atrial Fibrillation (AF)STREAMLINE PVINCT07910370
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
A study testing Pulsed Field Ablation (PFA) and Cryoballoon Ablation (Cryo) in people with Atrial Fibrillation (AF), run by St. Josefs-Hospital Wiesbaden GmbH at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pulsed Field Ablation (PFA) and Cryoballoon Ablation (Cryo)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- 26 Oct 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
St. Josefs-Hospital Wiesbaden
Wiesbaden, 65189
Joachim R Ehrlich, Prof. Dr., +49 611 177 1200, jehrlich@joho.de
Moritz Rothe, Dr., mrothe@joho.de
About this study
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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulsed Field Ablation (PFA), Cryoballoon Ablation (Cryo)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field Ablation (PFA)Procedure or surgery
Pulmonary vein isolation using the Medtronic PulseSelect system under conscious sedation.
Cryoballoon Ablation (Cryo)Procedure or surgery
Pulmonary vein isolation using the Medtronic Arctic Front Advance system under conscious sedation.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field Ablation (PFA) | Experimental | Patients randomized to this arm will undergo pulmonary vein isolation using pulsed field ablation (PFA) within a standardized Lean Six Sigma-optimized workflow. Receives: Procedure: Pulsed Field Ablation (PFA) |
| Cryoballoon Ablation (Cryo) | Active comparator | Patients randomized to this arm will undergo pulmonary vein isolation using cryoballoon ablation (Cryo) within a standardized Lean Six Sigma-optimized workflow. Receives: Procedure: Cryoballoon Ablation (Cryo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Procedure Duration
otal procedure duration, defined as the time from first vascular puncture to application of the venous compression bandage, measured in minutes.
Measured: During the ablation procedure
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 12 months after ablation
All-Cause Mortality
Proportion of patients experiencing death from any cause during follow-up.
Measured: Within 12 months after ablation
Stroke or Transient Ischemic Attack
Proportion of patients experiencing fatal or nonfatal stroke or transient ischemic attack (TIA).
Measured: Within 12 months after ablation
Cardiovascular Hospitalization
Proportion of patients requiring hospitalization for cardiovascular causes during follow-up.
Measured: 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.
Measured: Within 30 days after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start26 Oct 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910370
- Sponsor's protocol ID
- STREAMLINE PVI
- Acronym
- STREAMLINE PVI
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT07910370
- Acronym / sponsor ID
- STREAMLINE PVI / STREAMLINE PVI
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- St. Josefs-Hospital Wiesbaden GmbHUniversity, hospital or other
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation (PFA) | Experimental | Procedure: Pulsed Field Ablation (PFA)Patients randomized to this arm will undergo pulmonary vein isolation using pulsed field ablation (PFA) within a standardized Lean Six Sigma-optimized workflow. |
| Cryoballoon Ablation (Cryo) | Active comparator | Procedure: Cryoballoon Ablation (Cryo)Patients randomized to this arm will undergo pulmonary vein isolation using cryoballoon ablation (Cryo) within a standardized Lean Six Sigma-optimized workflow. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Field Ablation (PFA)Pulmonary vein isolation using the Medtronic PulseSelect system under conscious sedation. | Procedure or surgery | Pulsed Field Ablation (PFA) |
| Cryoballoon Ablation (Cryo)Pulmonary vein isolation using the Medtronic Arctic Front Advance system under conscious sedation. | Procedure or surgery | Cryoballoon Ablation (Cryo) |
Primary outcome
Total Procedure Duration
Time frame: During the ablation procedure
otal procedure duration, defined as the time from first vascular puncture to application of the venous compression bandage, measured in minutes.
9 secondary outcomes
Time to Post-Anesthetic Recovery
Time frame: Immediately after the ablation procedure until achievement of a score ≥9
Post-Anesthetic Recovery Score at 1 Hour
Time frame: 1 hour after the ablation procedure
Time to Same-Day Discharge Readiness
Time frame: Starting 4 hours after the ablation procedure until discharge readiness
Atrial Fibrillation/Atrial Tachycardia Burden
Time frame: 12 months after ablation
Recurrence of Atrial Arrhythmias
Time frame: Within 12 months after ablation
All-Cause Mortality
Time frame: Within 12 months after ablation
Stroke or Transient Ischemic Attack
Time frame: Within 12 months after ablation
Cardiovascular Hospitalization
Time frame: Within 12 months after ablation
Procedure-Related Complications
Time frame: Within 30 days after ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation (PFA) and Cryoballoon Ablation (Cryo) in people with Atrial Fibrillation (AF), run by St. Josefs-Hospital Wiesbaden GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joachim R Ehrlich, Prof. Dr. (+49 611 1771200, jehrlich@joho.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Procedure Duration (time frame: During the ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.