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NCT Number: NCT07745543

Redo-Pulmonary Vein Isolation With Versus Without Posterior Wall Ablation - 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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

Pulmonary vein isolation with posterior wall ablation

Procedure

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 ablation

Procedure

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.

Primary outcomes

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

    Time frame: Day 61-365 post-ablation

    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.

Secondary outcomes

  1. Treatment-emergent adverse events: Cardiac tamponade requiring drainage

    Time frame: Day 0-90 post-ablation

    Number of patients with cardiac tamponade requiring drainage after PVI

  2. Treatment-emergent adverse events: Persistent phrenic nerve palsy lasting >24 hours

    Time frame: Day 0-90 post-ablation

    Number of patients with persistent phrenic nerve palsy lasting >24 hours after PVI

  3. Treatment-emergent adverse events: Serious vascular complication requiring intervention

    Time frame: Day 0-90 post-ablation

    Number of patients with serious vascular complications requiring intervention after PVI

  4. Treatment-emergent adverse events: Stroke or TIA

    Time frame: Day 0-90 post-ablation

    Number of patients with stroke or TIA after PVI

  5. Treatment-emergent adverse events: Atrioesophageal fistula

    Time frame: Day 0-90 post-ablation

    Number of patients with atrioesophageal fistula after PVI

  6. Treatment-emergent adverse events: Death

    Time frame: Day 0-90 post-ablation

    Number of patients with fatal outcome/death after PVI

  7. Total procedure time

    Time frame: Day 0, during procedure

    Procedural endpoint; [min]

  8. Total left atrial indwelling time

    Time frame: Day 0, during procedure

    Procedural endpoint; [min]

  9. Total fluoroscopy time

    Time frame: Day 0, during procedure

    Procedural endpoint; [min]

  10. Total radiation dose

    Time frame: Day 0, during procedure

    Procedural endpoint; Calculated by multiplying the absorbed radiation dose (air kerma) by the cross-sectional area of the X-ray beam [cG*cm2]

  11. 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

    Procedural endpoint; [ng/L]

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

    Time frame: Day 0, shortly after ablation

    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).

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

    Time frame: Day 0, shortly after ablation

    Procedural endpoint

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

    Time frame: Day 0, shortly after ablation

    Procedural endpoint

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

    Time frame: Day 0, shortly after ablation

    Procedural endpoint

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

    Time frame: Day 0, shortly after ablation

    Procedural endpint; experimental group only

  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

    Time frame: up to 3 years

    Secondary endpoint during follow-up

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

    Time frame: Day 0-60 post-ablation

    Secondary endpoint during follow-up

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

    Time frame: Day 61-365 post-ablation

    Secondary endpoint during follow-up

  20. Arrhythmia burden for each participant between days 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)

    Secondary endpoint during follow-up

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

    Time frame: Day 0-365 post-ablation

    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.

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

    Time frame: up to 3 years

    Secondary endpoint during follow-up

  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)

    Time frame: up to 3 years

    Secondary endpoint during follow-up

  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

    Time frame: up to 1 year

    Secondary endpoint during follow-up

  25. Prevalence of persistent or paroxysmal atrial fibrillation

    Time frame: up to 3 years

    Secondary endpoint during follow-up

  26. Average heart rate

    Time frame: Months 1, 2 and 3 post-ablation

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

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

    Time frame: up to 3 years

    Incidence rate

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

    Time frame: up to 3 years

    Incidence rate

  29. Reinitiation or continuation of antiarrhythmic drug therapy

    Time frame: up to 3 years

    Incidence rate

  30. Electrical cardioversion due to recurrence

    Time frame: up to 3 years

    Incidence rate

  31. Number of reconnected veins evaluated during redo procedures

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

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

  32. Number of reconnected posterior walls evaluated during redo procedures

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

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

  33. Evolution of QoL

    Time frame: Day 90 and day 365 post-ablation

    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.

  34. Stroke or TIA (Transient ischemic attack)

    Time frame: 3, 12, 24 and 36 months

    Incidence rate

  35. All-cause death

    Time frame: after 3, 12, 24 and 36 months

    Incidence rate; cardiovascular or non-cardiovascular

Other outcomes

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

    Time frame: Day 61-365 post-ablation

    Subgroup analysis; scar is based on the 3D pre-ablation voltage map at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Badertscher, PD Dr. med.

CONTACT

[email protected]

+4161 556 58 23

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Boston Scientific Corporation
  • Swiss Heart Foundation

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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