AzTrials
AzTrials

Atrial Fibrillation (AF)NCT07745543

Redo-Pulmonary Vein Isolation With Versus Without Posterior Wall Ablation - The REDO-PIFPAF-PFA Study

A study testing Pulmonary vein isolation with posterior wall ablation and Pulmonary vein isolation without posterior wall ablation in people with Atrial Fibrillation (AF), run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study will compare two ablation strategies in patients with paroxysmal or persistent atrial fibrillation undergoing repeat ablation using pulsed-field ablation: redo pulmonary vein isolation only versus redo pulmonary vein isolation with added posterior wall ablation. 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?
Pulmonary vein isolation with posterior wall ablation and Pulmonary vein isolation without posterior wall ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
5 sitesSwitzerland
Study dates
Aug 2026to Jul 2031
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

  • Documented recurrence of paroxysmal or persistent AF following single prior catheter ablation with PVI, confirmed by 12-lead ECG, Holter monitoring, or ICM within the last 2 years.
  • Candidate for repeat catheter ablation according to current European Society of Cardiology (ESC) AF management guidelines.
  • Continuous oral anticoagulation with a vitamin K antagonist or non-vitamin K oral anticoagulant (NOAC) for ≥ 4 weeks prior to the ablation, or transoesophageal echocardiography (TEE) and/or cardiac computed tomography (CT) within 48 hours before the procedure excluding LA thrombus.
  • Age ≥ 18 years at the time of informed consent.
  • Written informed consent obtained prior to any study-related procedures.

Who cannot join

  • Previous LA surgery
  • > 1 prior LA ablation
  • LA ablation outside of the PVs in the first LA ablation
  • LA diameter >60 mm in the parasternal long axis
  • Patients in persistent AF lasting >3 years
  • AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
Show all 27Show fewer
  • Pre-existing PV stenosis or PV 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 procedure
  • Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including a patent foramen ovale)
  • New York Heart Association (NYHA) class III or IV congestive heart failure
  • Left ventricular ejection fraction (LVEF) <35%
  • Hypertrophic cardiomyopathy or left septal 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
  • 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 FU.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Patrick Badertscher, PD Dr. med. contact

+4161 556 58 23

patrick.badertscher@usb.ch

5 sites in 1 country

Switzerland5 sites
  • University Hospital Basel

    Basel, 4031

    Patrick Badertscher, PD Dr. med., +4161 556 58 23, patrick.badertscher@usb.ch

    Patrick Badertscher, PD Dr. med.

  • Bern University Hospital

    Bern, 3010

    Tobias Reichlin, Prof. Dr., +41 31 632 21 11, tobias.reichlin@insel.ch

    Tobias Reichlin, Prof. Dr.

  • University Hospital Lausanne

    Lausanne, 1011

    Patrizio Pascale, PD Dr. med., +41 21 314 48 00, patrizio.pascale@chuv.ch

    Patrizio Pascale, PD Dr. med.

  • Cantonal Hospital of St. Gallen

    Sankt Gallen, 9007

    Florian Franzeck, Dr. med., +41 71 494 10 51, florian.franzeck@h-och.ch

    Florian Franzeck, Dr. med.

  • University Hospital Zurich,

    Zurich, 8091

    Alexander Breitenstein, Prof. Dr., +41 44 255 20 99, alexander.breitenstein@usz.ch

    Alexander Breitenstein, Prof. Dr.

Other trials in Switzerland

About this study

Official title: Redo-Pulmonary Vein Isolation Using Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Atrial Fibrillation: A Multi-Centre Randomized Clinical Trial: The REDO-PIFPAF-PFA Study

The study will compare two ablation strategies in patients with paroxysmal or persistent atrial fibrillation undergoing repeat ablation using pulsed-field ablation: redo pulmonary vein isolation only versus redo pulmonary vein isolation with added posterior wall ablation.

Read the detailed description

In most patients, recurrence after ablation is caused by reconnection of previously isolated pulmonary veins (PV). However, atrial fibrillation (AF) recurrence may also result from progressive atrial remodelling, structural disease progression, and triggers originating outside the PVs. While there are multiple randomized controlled trials and clear recommendations for de novo ablations, there is a notable lack of studies and guideline recommendations for redo ablation procedures. Current practice therefore remains heterogeneous, and optimal lesion sets in the redo setting are not defined. The study aims to address this deficiency by undertaking a randomised comparison of two strategies that have already been adopted.

Being tested
Pulmonary vein isolation with posterior wall ablation, Pulmonary vein isolation without posterior wall ablation
Keywords
Pulmonary vein isolation, Pulsed field albation, posterior wall ablation
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 with posterior wall ablationProcedure or surgery

    Redo-pulmonary vein isolation with left atrial posterior wall ablation using pulsed-field ablation technology. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.

  • Pulmonary vein isolation without posterior wall ablationProcedure or surgery

    Redo-pulmonary vein isolation without left atrial posterior wall ablation using pulsed-field ablation technology. At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.

Study groups in NCT07745543
Study groupRoleWhat they receive
Intervention ArmExperimentalNot described
Receives: Procedure: Pulmonary vein isolation with posterior wall ablation
Control ArmActive comparatorNot described
Receives: Procedure: Pulmonary vein isolation without posterior wall ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first recurrence of any atrial tachyarrhythmia day 61-365

    Time to first recurrence of atrial tachyarrhythmia (atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT)) between day 61 and 365 post ablation as detected on an implantable cardiac monitor (ICM).

    AF, AFL or AT will be defined as an episode of at least 120 seconds (the shortest-duration episode that could be programmed for detection on the implantable cardiac monitor) with a continuous atrial arrhythmia of at least 30 seconds.

    Measured: Day 61-365 post-ablation

Secondary outcomes (35)
  1. Treatment-emergent adverse events: Cardiac tamponade requiring drainage

    Number of patients with cardiac tamponade requiring drainage after PVI

    Measured: Day 0-90 post-ablation

  2. 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

  3. 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

  4. Treatment-emergent adverse events: Stroke or TIA

    Number of patients with stroke or TIA after PVI

    Measured: Day 0-90 post-ablation

  5. Treatment-emergent adverse events: Atrioesophageal fistula

    Number of patients with atrioesophageal fistula after PVI

    Measured: Day 0-90 post-ablation

  6. Treatment-emergent adverse events: Death

    Number of patients with fatal outcome/death after PVI

    Measured: Day 0-90 post-ablation

  7. Total procedure time

    Procedural endpoint; [min]

    Measured: Day 0, during procedure

  8. Total left atrial indwelling time

    Procedural endpoint; [min]

    Measured: Day 0, during procedure

  9. Total fluoroscopy time

    Procedural endpoint; [min]

    Measured: Day 0, during procedure

  10. 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

  11. 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

  12. Post-ablation 3D-EAM: Assessment of atrial low-voltage/scar

    Procedural endpoint; Presence and extend of atrial low-voltage/scar will be assessed on 3D-EAM (three dimensional electroanatomical mapping.). Low-voltage areas will be identified on the basis of bipolar voltage mapping according to pre-specified mapping settings (rhythm during mapping, catheter type, point density, filtering) and recorded as (i) presence/absence and (ii) quantified surface area (cm²) within predefined left atrial regions (including posterior wall; optional: anterior wall; overall left atrium).

    Measured: Day 0, shortly after ablation

  13. Post-ablation 3D-EAM: Proportion of isolated veins

    Procedural endpoint

    Measured: Day 0, shortly after ablation

  14. Post-ablation 3D-EAM: Proportion of isolated carinas

    Procedural endpoint

    Measured: Day 0, shortly after ablation

  15. Post-ablation 3D-EAM: Lesion size

    Procedural endpoint

    Measured: Day 0, shortly after ablation

  16. Post-ablation 3D-EAM: Posterior wall ablation success rate

    Procedural endpint; experimental group only

    Measured: Day 0, shortly after ablation

  17. Time to first recurrence of any atrial tachyarrhythmia in patients with left atrial posterior wall scar and posterior wall ablation versus without posterior wall ablation

    Secondary endpoint during follow-up

    Measured: up to 3 years

  18. Arrhythmia burden for each participant between days 0-60 evaluated based on continuous ICM (Implantable cardiac monitor)

    Secondary endpoint during follow-up

    Measured: Day 0-60 post-ablation

  19. Arrhythmia burden for each participant between days 61 and 365 evaluated based on continuous ICM

    Secondary endpoint during follow-up

    Measured: Day 61-365 post-ablation

  20. Arrhythmia burden for each participant between days 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)

  21. Correlation of AF burden to symptoms and quality of life (QoL) 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

  22. Reduction of AF burden by > 90% post ablation procedure

    Secondary endpoint during follow-up

    Measured: up to 3 years

  23. Comparison of the prevalence of the type of arrhythmia recurrence during FU being atrial fibrillation or organized atrial arrhythmias (atrial flutter or atrial tachycardia)

    Secondary endpoint during follow-up

    Measured: up to 3 years

  24. Time to first recurrence of atrial tachyarrhythmia between days 61 and 365 in patients with presence of scar on the posterior wall based on the pre-ablation voltage map versus patients with no scar on the posterior wall evaluated based on continuous ICM

    Secondary endpoint during follow-up

    Measured: up to 1 year

  25. Prevalence of persistent or paroxysmal atrial fibrillation

    Secondary endpoint during follow-up

    Measured: up to 3 years

  26. Average heart rate

    Secondary endpoint during follow-up; as recorded by the ICM in months 1, 2 and 3 after ablation

    Measured: Months 1, 2 and 3 post-ablation

  27. Hospital or emergency room admission due to documented recurrence of atrial arrhythmias

    Incidence rate

    Measured: up to 3 years

  28. Repeat ablation procedure due to documented recurrence of atrial arrhythmias

    Incidence rate

    Measured: up to 3 years

  29. Reinitiation or continuation of antiarrhythmic drug therapy

    Incidence rate

    Measured: up to 3 years

  30. Electrical cardioversion due to recurrence

    Incidence rate

    Measured: up to 3 years

  31. Number of reconnected veins evaluated during redo procedures

    Secondary endpoint during follow up; sites of reconnection and size of antral scar area evaluated during redo procedures

    Measured: During redo procedures between day 1 to 36 months post-ablation

  32. Number of reconnected posterior walls evaluated during redo procedures

    Secondary endpoint during follow-up; sites of reconnection and size of the scar area evaluated during redo procedures

    Measured: During redo procedures between day 1 to 36 months post-ablation

  33. Evolution of QoL

    The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire is a 20-item, disease-specific tool used to measure how atrial fibrillation impacts a patient's daily life. Results are calculated on a scale from 0 (worst possible quality of life) to 100 (best possible quality of life).

    The EQ-5D-5L is a standardized, generic questionnaire used to measure health-related quality of life. The patient rates health on the current day across 5 areas: mobility, self-care; usual activities; Pain/discomfort; anxiety/depression. For each dimension, the patient chooses one of 5 severity levels: No problems;Slight problems;Moderate problems;Severe problems;Extreme problems / Unable to.

    Measured: Day 90 and day 365 post-ablation

  34. Stroke or TIA (Transient ischemic attack)

    Incidence rate

    Measured: 3, 12, 24 and 36 months

  35. All-cause death

    Incidence rate; cardiovascular or non-cardiovascular

    Measured: after 3, 12, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionJul 2031 (estimated)
  4. Study completionJul 2031 (estimated)

Resources

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
Model description
Multi-centre, randomized controlled superiority trial with a parallel cohort arm
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07745543
Sponsor's protocol ID
2026-00465; kt25badertscher2
Status last verified
Jul 2026
First submitted
29 Jul 2026
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary vein isolation with posterior wall ablation and Pulmonary vein isolation without posterior wall ablation in people with Atrial Fibrillation (AF), run by University Hospital, Basel, Switzerland at 5 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 5 inclusion and 27 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Contact Patrick Badertscher, PD Dr. med. (+4161 556 58 23, patrick.badertscher@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first recurrence of any atrial tachyarrhythmia day 61-365 (time frame: Day 61-365 post-ablation). 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 4 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in