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

NCT07745543 | Not Yet Recruiting DMC

• 1 other identifier: 2026-00465; kt25badertscher2
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Atrial Fibrillation (AF)

Keywords

Pulmonary vein isolation; Pulsed field albation; posterior wall ablation

Outcome Measures

Primary Outcomes (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.

  Day 61-365 post-ablation

Secondary Outcomes (35)

• Treatment-emergent adverse events: Cardiac tamponade requiring drainage

  Day 0-90 post-ablation

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

  Day 0-90 post-ablation

• Treatment-emergent adverse events: Serious vascular complication requiring intervention

  Day 0-90 post-ablation

• Treatment-emergent adverse events: Stroke or TIA

  Day 0-90 post-ablation

• Treatment-emergent adverse events: Atrioesophageal fistula

  Day 0-90 post-ablation

Other Outcomes (1)

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

  Day 61-365 post-ablation

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Procedure: Pulmonary vein isolation with posterior wall ablation

Control Arm

ACTIVE COMPARATOR

Procedure: Pulmonary vein isolation without posterior wall ablation

Interventions

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.

Intervention Arm

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss Heart Foundation: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (5)

University Hospital Basel

Basel, 4031, Switzerland

Location

Bern University Hospital

Bern, 3010, Switzerland

Location

University Hospital Lausanne

Lausanne, 1011, Switzerland

Location

Cantonal Hospital of St. Gallen

Sankt Gallen, 9007, Switzerland

Location

University Hospital Zurich,

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Badertscher, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Badertscher, PD Dr. med.

CONTACT

+4161 556 58 23; patrick.badertscher@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The independent clinical events committee (CEC) will remain blinded to treatment allocation throughout endpoint adjudication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centre, randomized controlled superiority trial with a parallel cohort arm

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Data will be made available on reasonable request.

Locations

CH (5)