Persistent Atrial FibrillationPIFPAF-PFANCT05986526
The PIFPAF-PFA Study
A study testing Pulmonary vein isolation without posterior wall ablation and Pulmonary vein isolation with posterior wall ablation in people with Persistent Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern at 6 sites in Switzerland.
Trial summary
Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation without posterior wall ablation and Pulmonary vein isolation with posterior wall ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 13 Nov 2023to 13 Feb 2028
- 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
- Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment
- Persistent atrial fibrillation is defined as a sustained episode lasting > 7 days
- Candidate for ablation based on current atrial fibrillation guidelines
- Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or CT scan that excludes left atrial thrombus ≤48 hours before the ablation procedure
- Age of 18 years or older on the date of informed consent
- Signed informed consent
Who cannot join
- Previous left atrial ablation or left atrial surgery
- Left atrial diameter >60 mm in the parasternal long axis
- Patients with paroxysmal atrial fibrillation
- Patients with persistent atrial fibrillation lasting >3 years
- AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
- Intracardiac thrombus
Show all 28Show fewer
- Pre-existing pulmonary vein stenosis or pulmonary vein stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Prior mitral valve surgery
- Severe mitral regurgitation or moderate/severe mitral stenosis
- Myocardial infarction during the 3-month period preceding the consent date
- Ongoing triple antithrombotic/anticoagulation therapy
- Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery/ transcatheter aortic valve implantation
- Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including a patent foramen ovale)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) <35%
- Hypertrophic cardiomyopathy (wall thickness >1.5 cm)
- Significant chronic kidney disease (eGFR <30 ml/min)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date
- Ongoing systemic infections
- History of cryoglobulinemia
- Cardiac amyloidosis
- Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women < 50 years before inclusion)
- Life expectancy less than one year per physician opinion
- Currently participating in any other clinical trial, which may confound the results of this trial
- Unwilling or unable to comply fully with the study procedures and follow-up
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Cantonal Hospital Baden
Baden
University Hospital Basel
Basel
Inselspital, University Hospital Bern
Bern, 3010
University Hospital Lausanne
Lausanne, 1011
Cantonal Hospital St. Gallen
Sankt Gallen
University Hospital Zürich
Zurich
About this study
Official title: Pulmonary Vein Isolation With Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Persistent Atrial Fibrillation - A Multi-Center Randomized Clinical Trial: The PIFPAF-PFA Study
Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Pulmonary vein isolation without posterior wall ablation, Pulmonary vein isolation with posterior wall ablation
- Keywords
- Pulmonary vein isolation, Pulsed field ablation, Left atrial posterior wall isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation without posterior wall ablationProcedure or surgery
Pulmonary vein isolation with Pulsed field ablation without left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring
Pulmonary vein isolation with posterior wall ablationProcedure or surgery
Pulmonary vein isolation with Pulsed field ablation with left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation without posterior wall ablation | Active comparator | Pulmonary vein isolation without left atrial posterior wall ablation Receives: Procedure: Pulmonary vein isolation without posterior wall ablation |
| Pulmonary vein isolation with posterior wall ablation | Active comparator | Pulmonary vein isolation with left atrial posterior wall ablation Receives: Procedure: Pulmonary vein isolation with posterior wall ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first recurrence of any atrial tachyarrhythmia day 91-365
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Measured: Day 91-365 post-ablation
Secondary outcomes (50)
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 91-365 evaluated based on continuous ICM
Key secondary efficacy endpoint
Measured: Day 91-365 post-ablation
Treatment-emergent adverse events: Cardiac tamponade requiring drainage
Number of patients with cardiac tamponade requiring drainage after PVI
Measured: Day 0-90 post-ablation
Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours
Number of patients with persistent phrenic nerve palsy lasting >24 hours after PVI
Measured: Day 0-90 post-ablation
Treatment-emergent adverse events: Serious vascular complication requiring intervention
Number of patients with serious vascular complications requiring intervention after PVI
Measured: Day 0-90 post-ablation
Treatment-emergent adverse events: Stroke or TIA
Number of patients with stroke or TIA after PVI
Measured: Day 0-90 post-ablation
Treatment-emergent adverse events: Atrioesophageal fistula
Number of patients with atrioesophageal fistula after PVI
Measured: Day 0-90 post-ablation
Treatment-emergent adverse events: Death
Number of patients with fatal outcome/death after PVI
Measured: Day 0-90 post-ablation
Time to first recurrence of any atrial tachyarrhythmia day 0-365
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Measured: Day 0-365 post-ablation
Time to first recurrence of any atrial tachyarrhythmia day 0-90
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Measured: Day 0-90 post-ablation
Total procedure time
Procedural endpoint; [min]
Measured: Day 0, during procedure
Total left atrial indwelling time
Procedural endpoint; [min]
Measured: Day 0, during procedure
Total fluoroscopy time
Procedural endpoint; [min]
Measured: Day 0, during procedure
Total radiation dose
Procedural endpoint; Calculated by multiplying the absorbed radiation dose (air kerma) by the cross-sectional area of the X-ray beam [cG*cm2]
Measured: Day 0, during procedure
Change in hs-troponin on Day 1 post-ablation compared with pre-procedural hs-troponin
Procedural endpoint; [ng/L]
Measured: Pre-procedural (day -1 or day 0) to day 1 post-ablation
Post-ablation 3D electro-anatomical mapping: Proportion of isolated veins
Procedural endpoint
Measured: Day 0, shortly after ablation
Post-ablation 3D electro-anatomical mapping: Posterior wall ablation success rate
Procedural endpoint; experimental group only
Measured: Day 0, shortly after ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-90 evaluated based on continuous ICM
Secondary endpoint during follow-up
Measured: Day 0-90 post-ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-365 evaluated based on continuous ICM
Secondary endpoint during follow-up
Measured: Day 0-365 post-ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 365 until explantation or end of life (EOL) of the ICM
Secondary endpoint during follow-up
Measured: Day 365 post-ablation to explantation of ICM or end of life of ICM (up to 4 years after implantation of ICM)
Correlation of AF burden to symptoms and quality of life changes
Secondary endpoint during follow-up; Quality of life will be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes; Symptoms will be measured with the AFEQT (Atrial Fibrillation Effect on Quality-of-life) questionnaire where higher scores mean worse outcomes
Measured: Day 0-365 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 91-365
Secondary endpoint during follow-up
Measured: Day 91-365 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 0-90
Secondary endpoint during follow-up
Measured: Day 0-90 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 0-365
Secondary endpoint during follow-up
Measured: Day 0-365 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 91-365
Secondary endpoint during follow-up
Measured: Day 91-365 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-90
Secondary endpoint during follow-up
Measured: Day 0-90 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-365
Secondary endpoint during follow-up
Measured: Day 0-365 post-ablation
Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation
Secondary endpoint during follow-up
Measured: Months 1, 2 and 3 post-ablation
Hospital or emergency room admission due to atrial arrhythmia recurrence
Incidence rate
Measured: Day 0-365 post-ablation
Repeat ablation due to recurrence of atrial arrhythmias
Incidence rate
Measured: Day 0-365 post-ablation
Electrical cardioversion due to recurrence
Incidence rate
Measured: Day 0-365 post-ablation
Reinitiation or continuation of antiarrhythmic drug therapy day 91-365
Incidence rate
Measured: Day 0-365 post-ablation
Number of reconnected pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Measured: During redo procedures between day 1 to 36 months post-ablation
Sites of reconnection (anterior, posterior, superior, inferior) of the pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Measured: During redo procedures between day 1 to 36 months post-ablation
Size of antral scar area (cm²) of the pulmonary veins evaluated during redo procedures
Secondary endpoint during follow-up
Measured: During redo procedures between day 1 to 36 months post-ablation
Number of reconnected posterior walls evaluated during redo procedures
Secondary endpoint during follow-up
Measured: During redo procedures between day 1 to 36 months post-ablation
Sites of reconnection of the posterior wall evaluated during redo procedures
Secondary endpoint during follow-up
Measured: During redo procedures between day 1 to 36 months post-ablation
Size of the scar area (cm²) of the posterior wall evaluated during redo procedures
Secondary endpoint during follow-up
Measured: During redo procedures between day 1 to 36 months post-ablation
EQ-5D-5L Composite score month 3
Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Composite score month 3.
Measured: Day 90 post-ablation
EQ-5D-5L Composite score month 12
Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Composite score month 12.
Measured: Day 365 post-ablation
EQ-5D-5L Visual analogue scale month 3
Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Visual analogue scale month 3.
Measured: Day 90 post-ablation
EQ-5D-5L Visual analogue scale month 12
Quality of life wil be measured with the EQ-5D-5L questionnaire where higher scores mean better outcomes. Visual analogue scale month 12.
Measured: Day 365 post-ablation
AFEQT month 3
Quality of life wil be measured with the AFEQT questionnaire.
Measured: Day 90 post-ablation
AFEQT month 12
Quality of life wil be measured with the AFEQT questionnaire.
Measured: Day 365 post-ablation
Stroke or transient ischemic attack day 0-365
Incidence rate
Measured: Day 0-365 post-ablation
All-cause death day 0-365
Incidence rate
Measured: Day 0-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥1 hour
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Measured: Day 91-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥6 hour
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Measured: Day 91-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥1 day
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Measured: Day 91-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥2 days
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Measured: Day 91-365 post-ablation
Time to first episode of atrial tachyarrhythmia day 91-365 lasting ≥7 days
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
Measured: Day 91-365 post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start13 Nov 2023
- Primary completion13 Feb 2026
- Study completion13 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies 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
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Roten, MD, Principal investigator, Inselspital, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986526
- Sponsor's protocol ID
- 2023-00885
- Other IDs
- 2023
- Acronym
- PIFPAF-PFA
- Status last verified
- Mar 2026
- First submitted
- 25 Jul 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Roten L, Maurhofer J, Krisai P, Breitenstein A, Koepfli P, Saguner AM, Franzeck F, Pascale P, Kueffer T, Knecht S, Jufer C, Spahiu V, Schaerli N, Herrera Siklody C, Thalmann G, Kozhuharov N, Kovacs B, Mahfoud F, Heg D, Pereira TV, Servatius H, Tanner H, Kuhne M, Sticherling C, Reichlin T, Juni P, Badertscher P. Pulmonary Vein Isolation Using Pulsed Field Ablation With vs Without Posterior Wall Isolation in Patients With Symptomatic Persistent Atrial Fibrillation: The PIFPAF-PFA Randomized Clinical Trial. JAMA. 2026 Aug 29. doi: 10.1001/jama.2026.17598. Online ahead of print.
PubMed 42667231
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Isolation With Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Persistent Atrial Fibrillation - A Multi-Center Randomized Clinical Trial: The PIFPAF-PFA Study
- ClinicalTrials.gov ID
- NCT05986526
- Acronym / sponsor ID
- PIFPAF-PFA / 2023-00885
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Pulmonary vein isolation, Pulsed field ablation, Left atrial posterior wall isolation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2028 (estimated)
- First posted
- 14 Aug 2023 (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.
Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation without posterior wall ablation | Active comparator | Procedure: Pulmonary vein isolation without posterior wall ablationPulmonary vein isolation without left atrial posterior wall ablation |
| Pulmonary vein isolation with posterior wall ablation | Active comparator | Procedure: Pulmonary vein isolation with posterior wall ablationPulmonary vein isolation with left atrial posterior wall ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Persistent atrial fibrillation documented on a 12 lead ECG, Holter monitor or implantable cardiac device within last 2 years of enrollment
- Persistent atrial fibrillation is defined as a sustained episode lasting > 7 days
- Candidate for ablation based on current atrial fibrillation guidelines
- Continuous anticoagulation with Vitamin-K-Antagonists or a NOAC for ≥4 weeks prior to the ablation; or a transesophageal echocardiography and/or CT scan that excludes left atrial thrombus ≤48 hours before the ablation procedure
- Age of 18 years or older on the date of informed consent
Key exclusion criteria (28 listed)
- Previous left atrial ablation or left atrial surgery
- Left atrial diameter >60 mm in the parasternal long axis
- Patients with paroxysmal atrial fibrillation
- Patients with persistent atrial fibrillation lasting >3 years
- AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
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 |
|---|---|---|
| Pulmonary vein isolation without posterior wall ablationPulmonary vein isolation with Pulsed field ablation without left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring | Procedure or surgery | Pulmonary vein isolation without posterior wall ablation |
| Pulmonary vein isolation with posterior wall ablationPulmonary vein isolation with Pulsed field ablation with left atrial posterior wall ablation. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring | Procedure or surgery | Pulmonary vein isolation with posterior wall ablation |
Primary outcome
Time to first recurrence of any atrial tachyarrhythmia day 91-365
Time frame: Day 91-365 post-ablation
Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between day 91 and 365 post ablation as detected on an implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 seconds or longer on the ICM (the minimum programmable episode interval)
50 secondary outcomes
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 91-365 evaluated based on continuous ICM
Time frame: Day 91-365 post-ablation
Treatment-emergent adverse events: Cardiac tamponade requiring drainage
Time frame: Day 0-90 post-ablation
Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours
Time frame: Day 0-90 post-ablation
Treatment-emergent adverse events: Serious vascular complication requiring intervention
Time frame: Day 0-90 post-ablation
Treatment-emergent adverse events: Stroke or TIA
Time frame: Day 0-90 post-ablation
Treatment-emergent adverse events: Atrioesophageal fistula
Time frame: Day 0-90 post-ablation
Treatment-emergent adverse events: Death
Time frame: Day 0-90 post-ablation
Time to first recurrence of any atrial tachyarrhythmia day 0-365
Time frame: Day 0-365 post-ablation
Time to first recurrence of any atrial tachyarrhythmia day 0-90
Time frame: Day 0-90 post-ablation
Total procedure time
Time frame: Day 0, during procedure
Total left atrial indwelling time
Time frame: Day 0, during procedure
Total fluoroscopy time
Time frame: Day 0, during procedure
Total radiation dose
Time frame: Day 0, during procedure
Change in hs-troponin on Day 1 post-ablation compared with pre-procedural hs-troponin
Time frame: Pre-procedural (day -1 or day 0) to day 1 post-ablation
Post-ablation 3D electro-anatomical mapping: Proportion of isolated veins
Time frame: Day 0, shortly after ablation
Post-ablation 3D electro-anatomical mapping: Posterior wall ablation success rate
Time frame: Day 0, shortly after ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-90 evaluated based on continuous ICM
Time frame: Day 0-90 post-ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 0-365 evaluated based on continuous ICM
Time frame: Day 0-365 post-ablation
Percentage of time with cardiac arrhythmia (arrhythmia burden) for each participant between day 365 until explantation or end of life (EOL) of the ICM
Time frame: Day 365 post-ablation to explantation of ICM or end of life of ICM (up to 4 years after implantation of ICM)
Correlation of AF burden to symptoms and quality of life changes
Time frame: Day 0-365 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 91-365
Time frame: Day 91-365 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 0-90
Time frame: Day 0-90 post-ablation
Time to first recurrence of atrial flutter/ atrial tachycardia day 0-365
Time frame: Day 0-365 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 91-365
Time frame: Day 91-365 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-90
Time frame: Day 0-90 post-ablation
Time to first recurrence of persistent or paroxysmal atrial fibrillation day 0-365
Time frame: Day 0-365 post-ablation
Average heart rate as recorded by the ICM in months 1, 2 and 3 after ablation
Time frame: Months 1, 2 and 3 post-ablation
Hospital or emergency room admission due to atrial arrhythmia recurrence
Time frame: Day 0-365 post-ablation
Repeat ablation due to recurrence of atrial arrhythmias
Time frame: Day 0-365 post-ablation
Electrical cardioversion due to recurrence
Time frame: Day 0-365 post-ablation
Reinitiation or continuation of antiarrhythmic drug therapy day 91-365
Time frame: Day 0-365 post-ablation
Number of reconnected pulmonary veins evaluated during redo procedures
Time frame: During redo procedures between day 1 to 36 months post-ablation
Sites of reconnection (anterior, posterior, superior, inferior) of the pulmonary veins evaluated during redo procedures
Time frame: During redo procedures between day 1 to 36 months post-ablation
Size of antral scar area (cm²) of the pulmonary veins evaluated during redo procedures
Time frame: During redo procedures between day 1 to 36 months post-ablation
Number of reconnected posterior walls evaluated during redo procedures
Time frame: During redo procedures between day 1 to 36 months post-ablation
Sites of reconnection of the posterior wall evaluated during redo procedures
Time frame: During redo procedures between day 1 to 36 months post-ablation
Size of the scar area (cm²) of the posterior wall evaluated during redo procedures
Time frame: During redo procedures between day 1 to 36 months post-ablation
EQ-5D-5L Composite score month 3
Time frame: Day 90 post-ablation
EQ-5D-5L Composite score month 12
Time frame: Day 365 post-ablation
EQ-5D-5L Visual analogue scale month 3
Time frame: Day 90 post-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 27 Jul 2026.
- Derived from this study: PubMed 42667231Roten L, Maurhofer J, Krisai P, Breitenstein A, Koepfli P, Saguner AM, Franzeck F, Pascale P, Kueffer T, Knecht S, Jufer C, Spahiu V, Schaerli N, Herrera Siklody C, Thalmann G, Kozhuharov N, Kovacs B, Mahfoud F, Heg D, Pereira TV, Servatius H, Tanner H, Kuhne M, Sticherling C, Reichlin T, Juni P, Badertscher P. Pulmonary Vein Isolation Using Pulsed Field Ablation With vs Without Posterior Wall Isolation in Patients With Symptomatic Persistent Atrial Fibrillation: The PIFPAF-PFA Randomized Clinical Trial. JAMA. 2026 Aug 29. doi: 10.1001/jama.2026.17598. Online ahead of print.
- Individual participant dataSharing planned: Yes
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Atrial Fibrillation
Recruiting
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
Persistent Atrial Fibrillation
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. This study is not recruiting at the moment.
Laurent Roten, MD principal investigator
Inselspital, University Hospital Bern
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation without posterior wall ablation and Pulmonary vein isolation with posterior wall ablation in people with Persistent Atrial Fibrillation, run by Insel Gruppe AG, University Hospital Bern at 6 sites in Switzerland.
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 6 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first recurrence of any atrial tachyarrhythmia day 91-365 (time frame: Day 91-365 post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05986526, which also lists 1 linked publication.
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 27 Jul 2026.